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Panthera D-SAD Classic oral appliance now eligible for Medicare reimbursement

Panthera has received notification from the Pricing, Data Analysis and Coding (PDAC) contractor, following their request for a coding decision for the Panthera      D-SAD Classic oral appliance. PDAC, following a formal review and assessment, has classified the HCPCS code (Healthcare Common Procedure Coding System) E0486 to be used when submitting claims for Medicare billing and other insurers who require PDAC verification following CMS (Centers for Medicare-Medicaid Services) policy.

Quebec, Canada, July 28, 2022. Panthera Dental (Quebec, Canada), a global leader in CAD/CAM implant solutions and dental sleep appliances, today announced they have received notification from PDAC that the Panthera D-SAD Classic can be billed for Medicare beneficiaries using the E0486 HCPCS code when submitting claims.

The Panthera Classic device is 3D printed, made from 100% medical-grade biocompatible polyamide 12 nylon. The versatility of medical grade nylon removes traditional limitations in design, allowing for thinness, thickness, rigidity, or flexibility. Its pull/traction mandibular advancement mechanism is aligned with the occlusal plane, which has been shown to exert less force on the TMJ than an oblique push/compression design, thereby reducing the risk of patients developing TMJ disorders during treatment.1

Panthera Dental is leading the dental-sleep industry in manufacturing principles utilizing 4.0 technology that incorporates robotics, AI and laser sintering. The resourcefulness of nylon enables it to take any shape allowing the Panthera Classic to boast over 350 customization options. The turn-around time to deliver the Panthera Classic anywhere within the US is 8 days which means patients could be starting treatment sooner.

The therapeutic benefits for Medicare and Non-Medicare patients will be significant. The high degree of precision in the CAD/CAM production process means that Panthera Classic appliances are perfectly matched to the dental records provided. The fit goes beyond millimetres in fitting a patient’s anatomy, up to the micron ranges of fit. This often means a drop in fit, less chair time, and increased patient comfort.

The high durability of polyamide 12 nylon, making it virtually indestructible, combined with the latest in manufacturing 4.0 precision technologies, allowed for the company’s recent decision to issue a unique new ‘360 Warranty’. Not only does it offer a free remake for any appliance that breaks during normal use within 36 months, but Panthera Dental will also replace any appliance free of charge during the first 60 days, no questions asked.

This is expected to give doctors and their Medicare patients unprecedented peace of mind when starting therapy.

“We are delighted that US practitioners can now offer our oral appliance therapy under Medicare” said Gabriel Robichaud, CEO and Co-Founder of Panthera Dental. “It’s a milestone, not just for Panthera Dental, but more importantly for Medicare patients who can now receive a treatment that is truly personalized in a way that can only be achieved by Industry 4.0 manufacturing.” He continued “Our aim has always been to improve provider’s experience with oral appliance, and to put our leading technology and inhouse dental expertise to work to build efficiencies within their practices. We look forward to help them treat even more patients in the future.”

Panthera Dental’s Digital Sleep Apnea Devices (D-SADs), the Panthera Classic and Panthera X3, have FDA 510(k) clearance for snoring and obstructive sleep apnea, bear the CE mark, and comply with the Canadian Medical Devices Regulations.

About Panthera Dental

Panthera Dental designs, manufactures and markets dental prosthetic, implantology and sleep breathing disorder solutions using an innovative CAD/CAM process and superior quality materials. Both a pioneer and a leader in the field of customized dental solutions, its proprietary technology allows it to offer next-generation products to the widest range of patients possible. Panthera Dental is headquartered in Quebec City, Canada, with subsidiaries in the USA, France and Germany, and associates worldwide.

Panthera Dental website: www.pantheradental.com

More information about Panthera Dental’s sleep division is available at www.pantherasleep.com

References:
1. Cheze L. Impact on temporomandibular joint of two mandibular advancement device designs. ITBM-RBM. 27(5–6):233–7. 2006

Contact
Panthera Dental
9105 rue John-Simons
Quebec, QC, Canada, G2B 0S6
Phone: + 1 (418) 527-0388
info@pantheradental.com

Kent Imaging Recognized as Most Innovative Medical Imaging Technology Developer in Canada

SnapshotNIR is enabling clinicians to drive better outcomes in wound care, limb preservation, and surgery, with its diagnostic-driven imaging technology.

NEWS PROVIDED BY Kent Imaging Inc. June 21, 2022, 16:20 GMT

Kent’s CEO, Pierre Lemire, with SnapshotNIR

 

CALGARY, AB, CANADA, June 21, 2022 /EINPresswire.com/ — Kent Imaging Inc. has been recognized by GHP (Global Health & Pharma, formerly AI Global) as the best medical imaging technology development company in Canada for the fourth consecutive year.

Kent Imaging Inc., is a leading Medtech firm based in Calgary, Alberta, Canada. The company’s technologies – namely SnapshotNIR – are enabling clinicians to drive better outcomes in wound care, limb preservation, and surgery, with its diagnostic-driven imaging technology that assesses tissue oxygenation. Consequently, Kent Imaging has, once again, earned itself the esteemed title of Best Medical Imaging Company in Canada for 2022.

“We are honored to have our efforts recognized by Global Health & Pharma,” expresses Kent’s CEO, Pierre Lemire. “One of our main focuses is building awareness around the issues, care requirements, and potential complications that can arise from diabetes or PAD-related chronic wounds. Effective wound management requires in-depth and consistent wound healing monitoring and our SnapshotNIR technology is changing the game in helping to drive more successful outcomes for patients.”

About Kent Imaging, Inc.
Kent Imaging, located in Calgary, Alberta, Canada, is a leading innovator in near-infrared tissue oxygenation imaging, which develops, manufactures, and markets medical technology that supports real-time decision-making in wound care, vascular and surgical subspecialties. Kent holds multiple patents in oxygen imaging technology and continues to provide innovative and advanced diagnostic imaging solutions to aid healthcare systems nationally and internationally. For more information about Kent Imaging, visit www.kentimaging.com

Leah Pavlick
Kent Imaging
+1 4035427314
leah@kentimaging.com

Egg Medical, Inc., Closes on $13 million Financing

Egg Medical, Inc., Closes on $13 million Financing

Arden Hills, MN (March 3rd, 2022) — Egg Medical, Inc., a medical device company commercializing technologies to reduce scatter radiation exposure during interventional angiographic procedures, today announced the closing of a $13 million financing round. The round was led by TVM Capital Life Science, a transatlantic venture capital firm investing in life science innovation. The proceeds from this financing will be used to accelerate commercialization of Egg Medical’s scatter radiation protection platform, the EggNest™. The EggNest protects staff in hospital x-ray labs (cardiac catheterization, electrophysiology, interventional radiology, and operating rooms) from x-ray exposure. Proceeds will also be used to develop future platforms that will expand Egg Medical’s offerings and further address unmet needs for healthcare professionals at risk of radiation-related illness due to long-term exposure to scatter radiation.

“Occupational exposure of hospital staff to x-rays during medical procedures is an important workplace risk. Almost everyone in the interventional cardiology and radiology profession knows someone with a radiation related illness. There have been minimal improvements in x-ray shielding over the past 30 years, leaving the medical teams working in these environments exposed to scatter radiation everyday” said Robert F. Wilson MD, Egg Medical CEO. “The EggNest platform addresses the problem of hospital personnel radiation exposure for everyone working in these environments by reducing the exposure to scatter radiation by over 90%.”

Joining the Egg Medical Board of Directors will be Dr. Luc Marengère, Managing Partner and Dr. Sascha Berger, General Partner, for TVM Capital Life Science, who both bring a track record of building successful entrepreneurial companies within life science start-ups.

Dr. Luc Marengère stated, “TVM Capital Life Science believes Egg Medical has a unique opportunity and approach to address a significant unmet need in protecting healthcare workers from the damaging consequences of scatter radiation. It has the potential to transform how procedures are performed by making staff safety a priority”. Dr. Sascha Berger added that “Egg Medical fits TVM’s investment philosophy of actively seeking investments in innovative later-stage health science companies, with an experienced and proven management team.”

About Scatter Radiation

Scatter radiation is a form of secondary radiation created when the primary x-ray beam used to image the patient’s anatomy during interventional fluoroscopy procedures is reflected off the patient’s body in the procedure room. Physicians and staff who work in these environments are exposed to scatter radiation during medical procedures (such as angioplasty, stenting, and transcatheter valve treatment), putting them at increased risk for long-term health effects. Mounting published data show a link between this occupational radiation exposure and cancer, cataracts, hypertension, and neuro-degenerative issues, despite the use of standard x-ray shielding.

About the EggNest™ XR

The EggNest™ XR is a comprehensive, scatter radiation protection system fully integrated into the workflow of the modern Cath Lab. The system is built on a novel carbon fiber platform with integrated radiation shielding that replaces the patient mattress on the x-ray table. It protects the entire medical team regardless of location, dramatically reducing scatter radiation exposure. Testing performed by the company and confirmed by independent hospital studies have shown that the EggNest™ system reduces room scatter radiation by over 91%.

 

 

CENTOGENE Announces CFO Transition and Appointment of Miguel Coego Rios as EVP Finance & Legal and Interim CFO

CENTOGENE Announces Nomination of Andreas Busch to Supervisory Board

CENTOGENE Announces USD 62 Million Aggregate Equity and Debt Financings to Support Growth Plan

CENTOGENE Announces Nomination of Kim Stratton as Chief Executive Officer

CAMBRIDGE, Mass. and ROSTOCK, Germany, and BERLIN, February 1, 2022 (GLOBE NEWSWIRE – Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on generating data-driven insights to diagnose, understand, and treat rare diseases, today announced the Company’s Supervisory Board’s nomination of Kim Stratton as Chief Executive Officer, transitioning from her prior designation as Interim CEO. In her role as CEO, Mrs. Stratton will now lead CENTOGENE’s ongoing important strategic evolution on its path to maximizing stakeholder value creation.

Kim Stratton commented, “I am excited to continue my journey at CENTOGENE and officially take on the role of Chief Executive Officer. I have known and followed CENTOGENE for many years and am deeply impressed by CENTOGENE’s potential for value creation as we execute on the next chapter of our strategy.”

Peer Schatz, Chairman of the Supervisory Board of CENTOGENE said, “We are very much looking forward to developing and executing on our opportunities with Kim Stratton as our Chief Executive Officer. Kim is a most impressive executive with great experience in rare diseases through her various roles in the pharmaceutical industry. We look forward to working with Kim and to translating the next phases of our strategy into value for patients and our stakeholders.”

This nomination follows the notification by Dr. Andrin Oswald, the Company’s Chief Executive Officer and Managing Director, that he has resigned from his position in order to focus on his recovery. On December 20, 2021, the Company announced that Dr. Oswald had taken a medical leave of absence. While Dr. Oswald is on a path to recovery, this will take some additional time, and Dr. Oswald has therefore decided, in consultation and mutual agreement with the Company’s supervisory board, to hand over the CEO position to Kim Stratton to ensure continued strong leadership. Dr. Oswald will continue to be available to CENTOGENE as an advisor to ensure a smooth leadership transition.

“After careful consideration, I have decided to extend my medical leave and to focus on the completion of my recovery,” said Dr. Andrin Oswald. “CENTOGENE is at a very important time in its development that requires continued strong leadership. It is therefore that I have decided to step down and to hand over my role to Kim Stratton. I have worked with Kim in previous roles and have the greatest respect for her leadership skills and her significant experience in rare diseases. I feel confident knowing the Company will be in the skilled hands of Kim, our highly experienced management team, and our talented and passionate employees.”

Peer Schatz, Chairman of the Supervisory Board of CENTOGENE added, “It has been a great pleasure to work with Andrin. We send our best wishes for his continued recovery and that he can regain his full health as soon as possible. We understand, support, and have great respect for his decision taken in the interest of the Company to now hand over his roles to Kim Stratton. In only a few months during Andrin’s tenure as CEO, he has transformed the company to become much stronger and more focused. He formed a very high-performing, new team and created a culture of efficiency, inclusive decision-making, and accountability. With this team, a very exciting strategy has been designed, which has the potential to have a profound impact on the reduction of the burden of rare diseases and to thereby also create significant stakeholder value.”

The transition of the CEO role is effective immediately. Kim Stratton’s appointment as a managing director will be formalized at the next shareholder meeting.

Kim Stratton has more than 25 years’ global commercial expertise in the biopharmaceutical space, with significant experience across multiple geographies, including the U.K., U.S., Europe, and emerging markets. Most recently, Stratton was CEO of Orphazyme A/S (ORPHA.CO), a biopharmaceutical company dedicated to developing treatments for patients living with rare diseases. Prior to this role, Mrs. Stratton worked at Shire Pharmaceuticals, where she served as Head International Commercial for Shire’s Specialty and Rare Diseases portfolio. Before Shire, Mrs. Stratton spent nearly 15 years at Novartis in a number of senior management roles, including global product development, commercial, marketing, general manager, and various global corporate functions, including government and external affairs. Stratton also currently serves as a non-executive director on the Boards of Recordati S.p.A, Novozymes A/S, and Vifor Pharma AG.

About CENTOGENE

CENTOGENE engages in diagnosis and research around rare diseases transforming real-world clinical, genetic, and multiomic data to diagnose, understand, and treat rare diseases. Our goal is to bring rationality to treatment decisions and to accelerate the development of new orphan drugs by using our extensive rare disease knowledge and data. CENTOGENE has developed a global proprietary rare disease platform based on our real-world data repository of over 600,000 patients representing over 120 different countries.

The Company’s platform includes epidemiologic, phenotypic, and genetic data that reflects a global population, as well as a biobank of patients’ blood samples and cell cultures. CENTOGENE believes this represents the only platform focused on comprehensive analysis of multi-level data to improve the understanding of rare hereditary diseases. It allows for better identification and stratification of patients and their underlying diseases to enable and accelerate discovery, development, and access to orphan drugs. As of December 31, 2020, the Company collaborated with over 30 pharmaceutical partners.

Follow us on LinkedIn

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws. Statements contained herein that are not clearly historical in nature are forward-looking, and the words “anticipate,” “believe,” “continues,” “expect,” “estimate,” “intend,” “project,” and similar expressions and future or conditional verbs such as “will,” “would,” “should,” “could,” “might,” “can,” and “may,” are generally intended to identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause CENTOGENE’s actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, the effects of the COVID-19 pandemic on our business and results of operations, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in our industry, the expense and uncertainty of regulatory approval, including from the U.S. Food and Drug Administration, our reliance on third parties and collaboration partners, including our ability to manage growth and enter into new client relationships, our dependency on the rare disease industry, our ability to manage international expansion, our reliance on key personnel, our reliance on intellectual property protection, fluctuations of our operating results due to the effect of exchange rates, our ability to streamline cash usage, our requirement for additional financing and our ability to continue as a going concern, or other factors. For further information on the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to CENTOGENE’s business in general, see CENTOGENE’s risk factors set forth in CENTOGENE’s Form 20-F filed on April 15, 2021, with the Securities and Exchange Commission (the “SEC”) and subsequent filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and CENTOGENE’s specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Media Contact:

CENTOGENE

Ben Legg
Corporate Communications
press(at)centogene(dot)com

Lennart Streibel
Investor Relations
investor.relations(at)centogene(dot)com 

Stern IR  

Brendan Payne
+1 (212) 698 8695
brendan.payne(at)sternir(dot)com

Acer Therapeutics Reports Q3 2021 Financial Results and Provides Corporate Update

NEWTON, MA – Nov. 19, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today reported financial results for the third quarter ended September 30, 2021 and provided an update on Acer’s recent corporate developments.
 
“This quarter was all about preparing regulatory filings to advance our pipeline products,” said Chris Schelling, CEO and Founder of Acer. “For ACER-001, we successfully submitted a 505(b)(2) NDA in August and received FDA’s acceptance for filing and substantive review of our NDA in October, setting up a PDUFA target action date in June 2022. For ACER-801 and EDSIVO™, our team has been working diligently to prepare INDs, with the goal to submit both to the FDA in Q4. Additionally, we further enhanced the value in the company through the issuance of a key formulation patent by the USPTO related to ACER-001 with an expiration date of 2036, and expansion of our leadership team with the recent addition of Alka Chawla, M.D., Vice President, Medical Director.”
 
Q3 2021 and Recent Highlights

  • ACER-001 (sodium phenylbutyrate)
    • Announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for the treatment of patients with Urea Cycle Disorders (UCDs), and assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 5, 2022
    • Announced that the U.S. Patent and Trademark Office (USPTO) has issued a key new ACER-001 (sodium phenylbutyrate) formulation composition of matter U.S. patent (No. 11,154,521), strengthening Acer’s proprietary position in the U.S. until 2036
  • ACER-801 (osanetant)
    • Submitted an Investigational New Drug (IND) application to FDA for ACER-801, a selective non-peptide neurokinin 3 receptor (NK3R) antagonist for the treatment of induced Vasomotor Symptoms (iVMS)
  • EDSIVO™ (celiprolol)
    • Continued preparation for an IND submission and Special Protocol Assessment (SPA) request for a Phase 3, randomized, double-blind, placebo-controlled, decentralized clinical trial (DiSCOVER) for EDSIVO™ for patients with COL3A1+ vascular Ehlers-Danlos Syndrome (vEDS)
    • Continued to offer www.discoverceliprolol.com as an educational tool for interested parties
  • Corporate
    • Hired Alka Chawla, M.D., Vice President, Medical Director, in September 2021. Dr. Chawla brings to Acer over 20 years of biopharmaceutical industry experience, including work in the development and optimization of drug-binding and cell-based assays and the purification of proteins, as well as expertise in the therapeutic areas of hematology, metabolic disorders, and oncology.  Dr. Chawla has served as a key team member for an FDA Advisory Committee Meeting, led clinical development programs, and has been responsible for monitoring and evaluating the clinical safety of numerous product candidates
    • Ended Q3 2021 with $14.2 million in cash and cash equivalents. Acer believes its cash and cash equivalents available as of September 30, 2021, plus the $10.0 million Second Development Payment in two tranches following FDA acceptance for filing and review of an NDA for ACER-001 in a UCD per the Collaboration Agreement with Relief Therapeutics Holding AG (Relief), will be sufficient to fund its currently anticipated operating and capital requirements into mid-2022, excluding support for the planned ACER-801 and EDSIVO™ clinical trials

 Anticipated Milestones

  • ACER-001 (sodium phenylbutyrate)
    • June 5, 2022: FDA has assigned a PDUFA target action date of June 5, 2022, following its acceptance for filing of the NDA for ACER-001 (sodium phenylbutyrate) for the treatment of patients with UCDs
  • ACER-801 (osanetant)
    • Q1 2022: Phase 2a clinical trial initiation is expected in Q1 2022 designed to evaluate ACER-801’s pharmacokinetics, efficacy and safety in postmenopausal women and to identify the optimal dosing strategy for subsequent efficacy trials in certain cancer patients with iVMS, dependent upon IND clearance and subject to additional capital

 

  • EDSIVO(TM) (celiprolol)
    • Q4 2021: Submission of the proposed EDSIVO™ pivotal trial in an IND and SPA request, and request for breakthrough therapy designation are anticipated in Q4 2021
    • Q1 2022: Initiation of the EDSIVO™ DiSCOVER pivotal clinical trial is expected in Q1 2022 subject to successful IND submission and clearance and SPA agreement, and obtaining additional capital required to conduct and complete the trial
  • ACER-2820 (emetine)
    • Ongoing: Further advancement of the emetine program for treatment of certain infectious diseases, including COVID-19, is dependent on Acer’s ability to raise non-dilutive capital

 
ACER-001, ACER-801 and EDSIVO™ (celiprolol) are investigational product candidates that have not been approved by FDA. There is no guarantee that these product candidates will receive regulatory authority approval in any territory or become commercially available for the indications under investigation.
 
Q3 2021 Financial Results
 
Cash position. Cash and cash equivalents were $14.2 million as of September 30, 2021, compared to $5.8 million as of December 31, 2020. Acer believes its cash and cash equivalents available as of September 30, 2021, plus the $10.0 million Second Development Payment in two tranches following FDA acceptance for filing and review of an NDA for ACER-001 in a UCD per the Collaboration Agreement with Relief, will be sufficient to fund its currently anticipated operating and capital requirements into mid-2022, excluding support for planned ACER-801 and EDSIVO™ clinical trials.
 
Research and Development Expenses. Research and development expenses were $1.4 million, net of collaboration funding of $3.5 million for the three months ended September 30, 2021, as compared to $3.2 million for the three months ended September 30, 2020. This decrease of $1.8 million was primarily due to the recognition of the $3.5 million of collaboration funding from the Collaboration Agreement with Relief, partially offset by increases in contract manufacturing expenses and employee-related expenses. Research and development expenses for the three months ended September 30, 2021 were comprised of $3.6 million related to ACER-001, offset by $3.5 million of collaboration funding; $0.9 million related to ACER-801; $0.3 million related to EDSIVOTM; and $0.1 million related to other development activities.
 
General and Administrative Expenses. General and administrative expenses were $1.8 million, net of collaboration funding of $1.0 million for the three months ended September 30, 2021, as compared to $2.7 million for the three months ended September 30, 2020. This decrease of $0.9 million was primarily due to the recognition of the $1.0 million of collaboration funding from the Collaboration Agreement with Relief, as well as a decrease in legal expenses, partially offset by increases in precommercial expenses and employee-related expenses.
 
Net Loss. Net loss for the three months ended September 30, 2021 was $3.3 million, or $0.23 net loss per share (basic and diluted), compared to a net loss of $5.9 million, or $0.51 net loss per share (basic and diluted), for the three months ended September 30, 2020.
 
For additional information, please see Acer’s Quarterly Report on Form 10-Q filed today with the SEC.
 
Completion of Financial Restatement
Acer has completed the restatement of its previously issued financial statements for the fiscal quarters ended March 31, 2021 and June 30, 2021 (Restated Periods), and has filed amended Quarterly Reports on Form 10-Q/A for the Restated Periods with the SEC. As previously disclosed in its Current Report on Form 8-K filed November 16, 2021, a non-cash error was made in the application of certain complex accounting guidance for collaboration agreements, and the revenue recognition associated with the previously disclosed collaboration and license agreement between Acer and Relief, which was entered into on March 19, 2021. The correction of this non-cash error resulted in a restatement of Acer’s unaudited condensed interim financial statements and financial data for the Restated Periods. The restatement had no impact on Acer’s cash position or operating expenses or its ongoing operations or future plans.

 

Acer Therapeutics Receives Notice of Allowance of Key U.S. Patent Application Covering ACER-001 Formulation

Notice of allowance of ACER-001 formulation composition of matter patent application strengthens proprietary position in U.S. until 2036

NEWTON, MA and GENEVA, SWITZERLAND  October 7, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, Relief Therapeutics Holding SA (SIX: RLF, OTCQB: RLFTF) (“Relief”), today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Acer’s patent application No. 17/196,416 for certain claims related to ACER-001 (sodium phenylbutyrate). The allowed patent claims in the application titled, “Palatable Compositions Including Sodium Phenylbutyrate and Uses Thereof,” include pharmaceutical composition claims covering ACER-001’s taste-masked, multi-particulate dosage formulation for oral administration.

The USPTO issues a patent Notice of Allowance after it determines a patent should be granted upon completion of any outstanding administrative requirements. Acer’s patent is expected to be issued in the fourth quarter of 2021 and expire in 2036. If it receives marketing approval for ACER-001, Acer intends to submit the patent for listing by the U.S. Food and Drug Administration (FDA) in its Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

“We are extremely pleased to have received this Notice of Allowance from the USPTO for our proprietary formulation of ACER-001 as we continue to advance its development to potentially treat patients with Urea Cycle Disorders (UCDs), Maple Syrup Urine Disease (MSUD) and other possible indications,” said Jeff Davis, Chief Business Officer at Acer. “This Notice marks another important milestone in our pursuit of possible ACER-001 commercialization while we prepare to bring this treatment to UCDs patients, subject to FDA’s approval of our ACER-001 New Drug Application.”

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, added, “In parallel to the patent application efforts in the U.S., Acer and Relief are pursuing similar claims in the European Patent Office to cover ACER-001 as we continue to execute on our plan to submit a Marketing Authorization Application for ACER-001 for the treatment of patients with UCDs in Europe in Q2/Q3 2022.”

Parties interested in the ACER-001 program for UCDs may sign up for updates at:

ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority. There can be no assurance that this product candidate will receive regulatory authority approval for marketing in any territory or become commercially available for the indications under investigation.

About UCDs

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2   The current treatment of patients with UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for patients with UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate and sodium phenylbutyrate, respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, frequency with which medication must be taken, required number of pills, and the high cost of the medication.3

About ACER-001

ACER-001 (sodium phenylbutyrate) is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a nitrogen-binding agent in development for use as adjunctive therapy in the chronic management of patients with UCDs involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). The formulation is a multi-particulate dosage formulation for oral administration consisting of a core center, a layer of active drug, and a taste-masked coating designed to avoid the bitter taste of sodium phenylbutyrate in the mouth while quickly dissolving in the low pH of the stomach. The ACER-001 NDA for UCDs is currently under FDA review with a PDUFA target action date of June 5, 2022. ACER-001 is also being developed for MSUD and has been granted orphan drug designation by the FDA for this indication. ACER-001 is an investigational product candidate which has not been approved by FDA, the European Medicines Agency (EMA), or any other regulatory authority.

About Acer Therapeutics Inc.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced Vasomotor Symptoms (iVMS); EDSIVO™ (celiprolol) for treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief for development and commercialization of ACER-001. For more information, visit www.acertx.com.

About RELIEF THERAPEUTICS Holding SA

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease. In addition, Relief’s recently completed acquisitions of APR Applied Pharma Research SA and AdVita Lifescience GmbH, bring to Relief a diverse pipeline of marketed and development-stage programs, a commercial infrastructure in selected European countries and an internal R&D capability, which Relief hopes to leverage for both internal pipeline products as well as for third party product development on a fee for service basis.

RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.

References

  1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
  2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
  3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.

 

CENTOGENE and Twist Bioscience to Develop Advanced Sequencing Tools to Make Genetic Testing Rapidly Accessible for More Patients With Rare Diseases

Combining Expertise to Advance Precision Medicine, While Enabling a More Efficient and Timely Diagnosis of Rare Diseases Around the World

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN and SOUTH SAN FRANCISCO, Calif., Oct. 06, 2021 (GLOBE NEWSWIRE) — Centogene N.V. (Nasdaq: CNTG), a commercial-stage Company focused on generating data-driven insights to diagnose, understand, and treat rare diseases, and Twist Bioscience Corporation (Nasdaq: TWST), a Company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, announced today that they have signed a contract to collaborate on the development and commercialization of custom assay kits for rare diseases. The resulting products will be designed to make genetic testing more accessible to patients and further drive the understanding of rare diseases. Financial details were not disclosed.

“We are excited to be working together with Twist as we seek to enable the most timely diagnosis for rare disease patients around the world,” said Andrin Oswald, M.D., Chief Executive Officer at CENTOGENE. “Not only will this help to provide patients with quicker and more comprehensive answers today, but it will generate insights to advance the precision medicine of tomorrow.”

The product offering will combine CENTOGENE’s rare disease diagnostic expertise powered by the world’s largest Bio/Databank of its kind with Twist Bioscience’s library preparation and target enrichment capabilities to deliver multiple assays for rare disease diagnosis and analysis. The aim is to increase genetic testing options for the one in 15 individuals that are diagnosed with a rare disease each year. Additionally, the insights generated through these products will augment the Bio/Databank on rare diseases and may contribute to the discovery and development of novel therapeutics to treat rare diseases in the future.

“Twist continues to deliver science-driven tools to enable the accurate identification of rare diseases,” said Emily M. Leproust, Ph.D., CEO and Co-Founder of Twist Bioscience. “We look forward to combining our robust NGS tools with CENTOGENE’s rare disease insights to truly deliver advanced solutions for research professionals globally.”

This agreement represents another significant step forward for CENTOGENE’s mission to drive novel insights and enable the cure of 100 rare diseases within the next 10 years. To learn more, visit: https://www.centogene.com/virtual-investor-event

About Twist Bioscience Corporation

Twist Bioscience is a leading and rapidly growing synthetic biology and genomics company that has developed a disruptive DNA synthesis platform to industrialize the engineering of biology. The core of the platform is a proprietary technology that pioneers a new method of manufacturing synthetic DNA by “writing” DNA on a silicon chip. Twist is leveraging its unique technology to manufacture a broad range of synthetic DNA-based products, including synthetic genes, tools for next-generation sequencing (NGS) preparation, and antibody libraries for drug discovery and development. Twist is also pursuing longer-term opportunities in digital data storage in DNA and biologics drug discovery. Twist makes products for use across many industries including healthcare, industrial chemicals, agriculture and academic research.

Rapid Micro Biosystems Announces Pricing of Initial Public Offering

Source: Rapid Micro Biosystems, Inc.
July 14, 2021 21:30 ET
LOWELL, Mass., July 14, 2021 (GLOBE NEWSWIRE) — Rapid Micro Biosystems, Inc. (Nasdaq: RPID) (“RapidMicro”), an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products, today announced the pricing of its initial public offering of 7,920,000 shares of its Class A common stock at a price to the public of $20.00 per share. All of the shares of Class A common stock are being offered by Rapid Micro. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Rapid Micro, are expected to be $158.4 million, excluding any exercise of the underwriters’ option to purchase additional shares. Rapid Micro’s Class A common stock is expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “RPID” on July 15, 2021. The offering is expected to close on July 19, 2021, subject to satisfaction of customary closing conditions. In addition, Rapid Micro has granted the underwriters a 30-day option to purchase up to an additional 1,188,000 shares of Rapid Micro’s Class A common stock at the initial public offering price less the underwriting discounts and commissions.

J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Cowen and Company, LLC and Stifel, Nicolaus & Company, Incorporated are acting as joint book-running managers of the offering.

A registration statement on Form S-1 (File No. 333-257431) relating to the offering has been filed with the Securities and Exchange Commission and became effective on July 14, 2021. The offering will be made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204 or email at prospectus-eq_fi@jpmchase.com; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at prospectus@morganstanley.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY, 11717, by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, telephone: (415) 364-2720 or email at syndprospectus@stifel.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Contacts

Media:

media@rapidmicrobio.com

Investors:

investors@rapidmicrobio.com

 

Acer Therapeutics Plans NDA Submission for ACER-001 in Q3 2021
Following Pre-NDA Meeting with FDA

NEWTON, MA and GENEVA, SWITZERLAND May 25, 2021 – Acer Therapeutics Inc. (Nasdaq: ACER)(“Acer”), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, and RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF)(“Relief”), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients, today announced the outcome of Acer’s pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for ACER-001 for the treatment of Urea Cycle Disorders (UCDs). ACER-001 is a proprietary immediate release multi- particulate powder formulation of sodium phenylbutyrate (NaPB) with a taste-masked coating. ACER- 001 is being developed in collaboration with Relief.

The purpose of the pre-NDA meeting was to discuss the content of Acer’s planned NDA submission. Based on FDA feedback, the Companies believe the proposed data package will be sufficient to support an NDA submission under the Section 505(b)(2) regulatory pathway of ACER-001 for the treatment of patients with UCDs. Following NDA submission and FDA determination of acceptance for filing, the FDA will conduct a substantive review before deciding upon the action on the application.

“We are pleased with the outcome of our recent pre-NDA meeting with FDA, supporting our belief that the studies and data we intend to include in our planned NDA for ACER-001 should be sufficient for NDA submission,” said Chris Schelling, CEO and Founder of Acer. “We remain on track to complete the NDA submission in Q3 2021, provided that we obtain agreement with the FDA on our initial pediatric study plan (iPSP).”

Jack Weinstein, CFO and Treasurer of Relief Therapeutics, added: “The outcome of the pre-NDA meeting with the FDA is highly encouraging and marks an important milestone in support of the development and potential commercialization of ACER-001 worldwide. We are pleased with the progress of the ACER-001 program and look forward to working with the Acer team to potentially bring to market an alternative to existing NaPB-based treatments.”

ACER-001 is an investigational product candidate which has not been approved by FDA. There can be no assurance that if submitted, an NDA will be accepted for filing and substantive review or, if filed, that an NDA would be approved.

About UCDs

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2 The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate (GPB) and sodium phenylbutyrate (NaPB), respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, the frequency with which medication must be taken, the number of pills, and the high cost of the medication.3

About ACER-001

ACER-001 is being developed for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 is a proprietary immediate release powder formulation of sodium phenylbutyrate (NaPB). The formulation is a multi-particulate dosage formulation for oral administration consisting of a core center, a layer of active drug, and a taste-masked coating designed to avoid the bitter taste in the mouth while quickly dissolving in the low pH of the stomach. ACER-001’s taste-masked formulation is aimed to improve the palatability of NaPB. Acer has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is under clinical investigation and its safety and efficacy have not been established. There is no guarantee that this product candidate will receive U.S. FDA approval or become commercially available for the indications under investigation.

About Acer Therapeutics Inc.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-801 (osanetant) for the treatment of induced Vasomotor Symptoms (iVMS); and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. In March 2021, Acer entered into a Collaboration and License Agreement with Relief Therapeutics for the worldwide development and commercialization of ACER-001. For more information, visit www.acertx.com.

About RELIEF THERAPEUTICS Holding AG

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100™ (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the

  • for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, in March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste- masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.

References
  1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle; 1993.
  2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
  3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider perspectives. Mol Genet Metab. 2016;8:43-47.
Acer Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of management’s attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

Relief Forward-Looking Statements

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG and its businesses. The results reported herein may or may not be indicative of the results of future and larger clinical trials for ACER-001 for the treatment of UCDs and MSUD, nor whether the ongoing clinical trials of Relief’s lead compound, RLF-100™ (aviptadil) in advanced clinical development to treat respiratory deficiency due to COVID-19, will be successful. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

 

Relief and Acer Therapeutics Sign Collaboration and License Agreement for Worldwide Development and Commercialization of ACER-001 for the Treatment of Urea Cycle Disorders and Maple Syrup Urine Disease

Relief to potentially pay Acer up to $36 million and royalties in exchange for net profit share and territory rights
ACER-001 pre-NDA meeting with U.S. FDA scheduled in Q2 2021

GENEVA, SWITZERLAND and NEWTON, MA March 22, 2021 – RELIEF THERAPEUTICS Holding AG (SIX:

RLF, OTCQB: RLFTF)(“Relief”), a biopharmaceutical company with its lead compound RLF- 100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients, and Acer Therapeutics Inc. (Nasdaq: ACER)(“Acer”), a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced that the companies entered into a Collaboration and License Agreement (“CLA”) for worldwide development and commercialization of ACER-001. ACER- 001 is a proprietary powder formulation of sodium phenylbutyrate (NaPB) designed to be both taste- masked and immediate release.

Under the terms of the CLA, Acer will receive an approximately $10 million cash payment within 15 business days of CLA execution (originally $14 million, to be offset by repayment of the $4.0 million outstanding balance of the prior loan, plus interest, from Relief to Acer). Relief will also pay Acer up to $20 million in U.S. development and commercial launch costs for the UCDs and MSUD indications. Acer will retain development and commercialization rights in the U.S., Canada, Brazil, Turkey, and Japan.

The companies will split net profits from Acer’s territories 60%:40% in favor of Relief. In addition, Relief has licensed the rights for the rest of the world, where Acer will receive from Relief a 15% royalty on all revenues received in Relief’s territories. Acer may also receive a total of $6 million in development milestone payments following the first European (EU) marketing approvals for UCDs and MSUD.

Jack Weinstein, Chief Financial Officer and Treasurer of Relief, said, “We are excited to continue moving forward with the Acer team to develop and commercialize ACER-001 around the globe to address important unmet needs for patients suffering from these rare diseases. This collaboration is an important step in Relief’s plan to build a diversified late-stage pipeline beyond our lead candidate, RLF- 100™, which is currently in development for the treatment of respiratory illnesses due to COVID-19 infection. We are pleased to have been able to conclude this agreement, as the advanced stage of development and market opportunity with ACER-001 make this compound a perfect fit for Relief’s strategy.”

Chris Schelling, Acer’s CEO and Founder, said, “Our collaboration with Relief will provide important resources and additional expertise to advance the development of ACER-001 toward our goal of bringing this product candidate to patients suffering from UCDs and MSUD. We look forward to partnering with the team at Relief to advance this program and to potentially provide a much-needed treatment option for patients with these rare and debilitating diseases.”

An ACER-001 pre-NDA meeting with the U.S. FDA is scheduled to occur in the second quarter of 2021. Acer expects to receive official meeting minutes approximately 30 days after the meeting.

ACER-001 is an investigational product being studied for the treatment of patients with UCDs and MSUD and has not been approved by the U.S. FDA or any regulatory agency outside the U.S. for any indication. There can be no assurance that if submitted, a New Drug Application or equivalent will be accepted by the U.S. FDA or any other regulatory agency for filing and review or, if filed, that it will be approved.

About Urea Cycle Disorders (UCDs)

UCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2

The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for UCDs include nitrogen scavengers, RAVICTI® and BUPHENYL®, in which the active pharmaceutical ingredients are glycerol phenylbutyrate (GPB) and sodium phenylbutyrate (NaPB), respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications have been shown to be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, the frequency with which medication must be taken, the number of pills, and the high cost of the medication.3

About Maple Syrup Urine Disease (MSUD)

MSUD is a rare inherited disorder caused by defects in the mitochondrial branched-chain ketoacid dehydrogenase complex, which results in elevated blood levels of the branched-chain amino acids (BCAA), leucine, valine, and isoleucine, as well as the associated branched-chain ketoacids (BCKA) in a patient’s blood. Left untreated, this can result in neurological damage, mental disability, coma or death. There are currently no approved pharmacologic therapies in the U.S. or the European Union for MSUD. Treatment of MSUD consists primarily of a severely restricted diet to limit the intake of BCAA, with aggressive medical interventions when blood-levels of BCAA or BCKA become elevated.

About ACER-001

ACER-001 is a proprietary powder formulation of sodium phenylbutyrate (NaPB). The formulation is designed to be both taste-masked and immediate release. ACER-001 is being developed using a microencapsulation process for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 microparticles consist of a core center, a layer of active drug, and a taste- masking coating that quickly dissolves in the stomach, to avoid a bitter taste while still allowing for rapid systemic release. If ACER-001 is approved, its taste-masked properties could make it a compelling alternative to existing NaPB-based treatments, as the unpleasant taste associated with NaPB is cited as a major impediment to patient compliance with those treatments.3 Acer has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is under clinical investigation and its safety and efficacy have not been established. There is no guarantee that this product candidate will receive U.S. FDA approval or become commercially available for the uses being investigated.

About RELIEF THERAPEUTICS Holding AG

Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale. Relief’s lead drug candidate RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. for the treatment of respiratory deficiency due to COVID-19. As part of its pipeline diversification strategy, In March 2021, Relief entered into a Collaboration and License Agreement with Acer Therapeutics for the worldwide development and commercialization of ACER-001. ACER-001 is a taste-masked and immediate release proprietary powder formulation of sodium phenylbutyrate (NaPB) for the treatment of Urea Cycle Disorders and Maple Syrup Urine Disease.

RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbol RLFTF. For more information, visit www.relieftherapeutics.com. Follow Relief on LinkedIn.

About Acer Therapeutics Inc.

Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acer’s pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-801 (osanetant) for the treatment of induced Vasomotor Symptoms (iVMS); and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acer’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the U.S. FDA. On March 19, 2021, Acer entered into a Collaboration and License Agreement with Relief Therapeutics for worldwide development and commercialization of ACER-001. For more information, visit www.acertx.com.

References
  1. Ah Mew N, et al. Urea cycle disorders overview. Gene Reviews. Seattle, Washington: University of Washington, Seattle;
  2. Häberle J, et al. Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases. 2012;7(32).
  3. Shchelochkov OA, et al. Barriers to drug adherence in the treatment of urea cycle disorders: Assessment of patient, caregiver and provider Mol Genet Metab. 2016;8:43-47.
Relief Forward-Looking Statements

This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG and its businesses. The results reported herein may or may not be indicative of the results of future and larger clinical trials for ACER-001 for the treatment of UCDs and MSUD, nor whether the ongoing clinical trials of Relief’s lead compound, RLF-100™ (aviptadil) in advanced clinical development to treat respiratory deficiency due to COVID-19, will be successful. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of RELIEF THERAPEUTICS Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Acer Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the benefits and results of the Collaboration and License Agreement between Acer and Relief with respect to ACER-001; the potential for ACER-001 to target diseases; the adequacy of Acer’s capital to support its future operations and its ability to successfully continue its development programs; Acer’s ability to secure the additional capital necessary to fund its various product candidate development programs; and the development and commercial potential of any of Acer’s product candidates including ACER-001. Acer may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with Acer’s ability to benefit from and achieve the results contemplated by the Collaboration and License Agreement with Relief, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund Acer’s various product candidate development programs and to meet its business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Acer’s intellectual property, risks related to the drug discovery and the regulatory approval process and the impact of competitive products and technological changes. Acer disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures Acer makes in its filings with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q and its Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

CORPORATE CONTACTS

 RELIEF THERAPEUTICS Holding AG:

Jack Weinstein

Chief Financial Officer and Treasurer contact@relieftherapeutics.com

ACER Therapeutics:

Jim DeNike

Acer Therapeutics Inc.

+1 844-902-6100

jdenike@acertx.com

MEDIA CONTACTS

Relief (Europe):

Anne Hennecke / Brittney Sojeva MC Services AG

relief@mc-services.eu

+49 (0) 211-529-252-14

INVESTOR RELATIONS CONTACTS

Relief (Europe):

Anne Hennecke / Brittney Sojeva MC Services AG

relief@mc-services.eu

+49 (0) 211-529-252-14

Acer Therapeutics: Hans Vitzthum LifeSci Advisors

+1 617-430-7578

hans@lifesciadvisors.com

Access Vascular, Inc. Secures $20 Million in Series B Financing

Bedford, MA – 03 March, 2021-

Access Vascular, Inc., a company addressing the most common and costly venous access complications, today announced it has closed on a Series B round of financing. TVM Capital Life Science led the round with a $15 million commitment, with existing investors also participating.

Access Vascular has developed a proprietary biomaterial platform that is both hydrophilic and lubricious, and has incorporated this material into two commercially-available venous access devices, the HydroPICC® Peripherally Inserted Central Catheter and HydroMID™ Midline Catheter. In vitro studies have shown that this biomaterial technology results in an average of 97% less thrombus accumulation on its surface compared to a standard polyurethane catheter.*

The new financing will be used to generate post-market data on its two commercial devices designed to reduce thrombus accumulation and catheter occlusions, expand its portfolio of devices, and commercialize the portfolio of products.

“We are extremely pleased to partner with TVM Capital Life Science, a world-class venture capital firm with an extensive track record of successfully investing in, and supporting, earlystage commercial companies in order to maximize their growth potential,” said Access Vascular CEO James Biggins. “Their commitment to partnering with Access Vascular validates our conviction to continue solving critical issues in the vascular access space with our growing portfolio of proprietary technologies.”

“We believe that Access Vascular’s products can address the biggest unmet needs in the vascular access space. Their unique biomaterial technology shows a substantial reduction in the body’s biological response to the catheter, minimizing potential complications,” said Luc Marengere, PhD, Managing Partner, TVM Capital Life Science. “With our partnership, Access Vascular will be able to bring their innovative solutions to more patients, with the intent to improve outcomes and deliver higher procedural acuity.”

As part of the investment, Managing Partner Dr. Luc Marengere and Principal Dr. Alexandra MacLean, with TVM Capital Life Science, will join the Access Vascular Board of Directors.

About Access Vascular
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and are capable of long-term thrombus resistance.

About TVM Capital Life Science
TVM Capital Life Science is providing venture capital to the international pharmaceutical, biopharmaceutical and medical technology industries with more than 35 years of transatlantic investment track record and more than US $2.0B raised. With its advisory, corporate finance and investment teams located in Montreal and Munich, the TVM Capital Life Science team provides investors, as well as entrepreneurs and innovation-seeking biopharmaceutical companies, access to global life science innovation and provides paths for successful tech transfer and commercialization for the benefit of patients and investors alike. The TVM Capital Life Science team looks back on more than 140 investments and over 100 exits, including more than 45 initial public offerings on all major U.S. and European stock exchanges. The team has gained unrivalled international investment and business development experience with their track record of dedicated board work, significant contribution to global networks in the world of life science research and product development, and a direct knowledge
of the local markets.

More information: www.tvm-lifescience.com
*Data on file. Reduction of thrombus accumulation evaluated using in vitro and in vivo models. Pre-clinical in vitro/in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

 

Kent Imaging Becomes Net Health’s First Integrated Imaging Device

By David Godkin, Staff Writer
TORONTO – Think of it. More than 14,000 facilities boasting 98% of the largest hospital chains across the U.S., two-thirds of skilled nursing facilities and hospice organizations and doctors’ offices. It’s that broad customer base Kent Imaging Inc. will have access to following its Jan. 26 agreement with medical software and analytics giant Net Health Inc., helping to expand the footprint of Kent Imaging’s Snapshot device for assessing non-healing wounds, notably those arising from diabetes.
“The business of treating wounds is really tricky, anyone who’s doing it knows it’s a complex task,” Kent Imaging CEO Pierre Lemire told BioWorld. “Our goal is to have all Net Health customers adopting this technology because it can significantly impact their ability to treat patients, reducing complications and improving outcomes.”
Follow the light
Talk to any doctor treating a diabetic foot ulcer and you’ll learn two things: poor oxygenation makes it extraordinarily difficult for the wound to heal. Second there is an enormous lack, a clear, unmet need across the globe of appropriate, ongoing medical assessment of non-healing wounds. Too many doctors are hamstrung by a lack of insight into specific, non-healing wounds such as those that arise from diabetic neuropathy of the foot.
The agreement with Pittsburgh-based Net Health’s Tissue Analytics Inc. unit will marry its recently announced application-programming interface (API) with Kent Imaging’s Snapshot, which utilizes near-infrared light to determine how much tissue oxygen saturation has, or has not occurred, in a wound. There are many ways to treat diabetic foot ulcers, for example, but absent a better way to understand this, doctors don’t know which therapy to use at any stage of wound development.

The answer, said Lemire, comes courtesy of a simple biological principle: Whenever a molecule encounters light, properties within that molecule determine how much of that light is absorbed and how much is reflected. The trick in wound care is to know what happens when oxygenated and de-oxygenated hemoglobin contained in tissue respond to light. Hence the development of Snapshot, said Lemire.
“We use different bandwidths of light, primarily near-infrared light and based on how that light is reflected from the tissue we can determine how much oxygenated and de-oxygenated hemoglobin is in the tissue. This is critical for understanding tissue damage in diabetic foot ulcers, for example.”
Back in 2017 researchers were wrestling with another problem, one shared, curiously enough, with Apple. The same properties of light that impeded the performance of the Apple Watch worn by people with darker skin or tattoos made it difficult for researchers at Calgary, Alberta-based Kent Imaging to build an imaging device for wound and tissue oxygenation measurement for the same group.
Today’s Snapshot is a major upgrade of the hand-held device that solved that problem in 2017, the KD203 multispectral imaging device. It measures the percentage of hemoglobin carrying oxygen along smaller blood vessels to the wound site, as distinct from pulse oximetry which measures oxygenation of much larger carrier vessels, but not of the surrounding tissues.
A brighter path to prosperity
It’s that kind of targeted efficacy and sales revenue backstopping continued development of the device that earned the attention. Kent Imaging’s Snapshot device measures the percentage of hemoglobin carrying oxygen along the smaller blood vessels and veins to the diabetic wound site.
©2021 BioWorld. Reprinted with permission from Clarivate.

Dentsply Sirona and Panthera Dental announce collaboration: fully digital workflow for custom-made sleep devices

(Charlotte/Quebec, November 12, 2020)

Dentists now have the opportunity to use Primescan in a new area of application: Obstructive Sleep Apnea (OSA) and snoring, which affects up to 3.61 billion people worldwide and is a growing market. Dentsply Sirona has therefore signed an agreement to collaborate with Panthera Dental (Quebec, Canada) to offer a validated and fully digital workflow for custom-made sleep devices.

Dentsply Sirona’s intraoral scanner Primescan, launched in 2019, enables high-precision digital impressions with outstanding imagery. Working with Primescan offers numerous advantages: it can be used for patient consultation, treatment planning in implant dentistry and orthodontics, and for restorative treatments. With the collaboration between Dentsply Sirona and Panthera Dental, which was announced today, dentists can now use the precise scans in a validated workflow as a basis to create a custom-made Digital Sleep Apnea Device (D-SAD). The outstanding quality of the intraoral scan data delivers reliable data for the high-quality custom-made D-SAD Mandibular Advancement Device (MAD), indicated for people suffering from Obstructive Sleep Apnea and snoring.

Three steps to D-SAD: scan, send and treat

Thanks to Dentsply Sirona’s Primescan, a complete and accurate full-arch scan is possible in as little as a minute to give the dentist immediate control of a 3D model. The outstanding accuracy and reliable quality of Primescan delivers reliable data for the Panthera Dental D-SAD custom-made sleep device. This saves time and nearly eliminates the necessity for adjustments during patient visits.

The data transfer to Panthera Dental is fast and secure: for North America, Germany, France, Belgium, Netherlands, Luxembourg, United Kingdom, Australia and New Zealand the data will be transferred securely via the Dentsply Sirona Connect Case Center. For other Primescan and Panthera Dental countries the data can be sent via STL to Panthera Dental through their user-friendly web portal (regulations per country and availability may vary). With one of the next software versions, there will be a full integration in the Connect Case Center for all Primescan and Panthera Dental-validated countries.

One advantage is that besides Primescan, no additional equipment is needed. After scanning the patient’s complete jaw and the bite registration for the protrusion, the scan data can be sent directly to Panthera Dental, either using the Connect Case Center or via STL-file. Within 15 days, the D-SAD will be designed and manufactured by Panthera Dental’s proprietary CAD/CAM process in their 4.0 manufacturing plant using numerous digital, robotic and automated technologies. It is then shipped back to the dental professional via multinational express delivery service. The dentist receives a custom-made sleep device and can start treatment immediately.

The individualized and fast result distinguishes the dental practice in its treatment of snoring and sleep apnea, and allows for happier, healthier patients with improved quality of life.

A fast and accurate solution for OSA and snoring

Physical and psychological problems that sleep apnea can cause should not be underestimated. If sleep is constantly disturbed, this can have serious effects on mental and physical health. Currently, three main treatment solutions are recommended by experts: lifestyle modifications (weight loss and exercise), Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Devices (MAD). However, sleep masks (CPAP) have considerable compliance issues with 50% and 83% of patients being non-compliant after six months and five years respectively.2 Patient compliance of Mandibular Advancement Devices (MAD) remains 86% after over three years of use3. Thanks to Panthera Dental’s D-SAD, patients with Obstructive Sleep Apnea (OSA), and those who refuse or are noncompliant to Continuous Positive Airway Pressures (CPAP) therapy, have a comfortable and effective treatment option available.

Dr. Shouresh Charkhandeh, dentist and dental sleep medicine educator from Canada, says: “Over one billion people worldwide suffer from sleep-related breathing disorders such as Obstructive Sleep Apnea. Many of them can benefit from Oral Appliance Therapy (OAT). We need to safely simplify OAT and make it predictable in order for many dentists to get involved in providing this life-saving treatment to patients. The validated digital workflow solution between Primescan and Panthera Dental, which combines Primescan’s impressive accuracy, efficiency and ease of use, with Panthera Dental’s precise and versatile manufacturing, enables dentists around the world to help many suffering patients live a longer, better and healthier life and provide an alternative solution to CPAP therapy.”

Panthera Dental’s D-SAD is made out of 100% medical grade biocompatible type-12 polyamide nylon. This cutting-edge material is light, smooth, strong yet flexible, very durable and resistant to bruxism. A wide range of plateaus and bands are available and allow for over 300 standard design combinations as well as maximized tongue space. Additional customization is possible, and the D-SAD can be adapted to every possible patient morphology, from basic to the most complex. It is a uniquely simple and easy to care for dental appliance.

The D-SAD’s unique titration mechanism uses interchangeable rods made of the same biocompatible polymer as the device, designed to not elongate and resist to bruxism. The length of the rods varies from 16 to 34 mm and can be adjusted in 0.5 mm increments for an accurate and customized advancement. Moreover, they do not disengage during sleep thanks to a patented connection system and they are easily replaced.

“We are fulfilling an explicit request from customers and providing added value for dentists working with Primescan,” said Dr. Alexander Völcker, Group Vice President CAD/CAM at Dentsply Sirona. “The combination of Panthera Dental’s Digital Sleep Apnea Devices and Primescan is a great example of what can be achieved when a dental workflow starts with an intraoral scan. The digital technology integrates seamlessly into the daily workflow, enabling clinicians to provide a fast and accurate solution for sleep apnea and snoring.”

Beatrice Robichaud, Co-Founder and VP Marketing & Customer Experience at Panthera Dental said: “Our collaboration with Dentsply Sirona is a natural fit that will synergize both our companies’ recent technological advancements in the field of CAD/CAM solutions. Dentists worldwide will benefit from the predictability of the validated Primescan workflow while delivering an accurate, completely customized Digital Sleep Apnea Device to their patients, for greater patient satisfaction and quality of life.”

The Panthera D-SAD received FDA 510(k) clearance for snoring and obstructive sleep apnea has the CE mark and complies with the Canadian Medical Devices Regulations.

More information about Primescan is available on the Dentsply Sirona Website: www.dentsplysirona.com/primescan 

More information about Panthera Dental is available on the Panthera Dental website: https://pantheradental.com/d-sad/

The workflow is being expanded to other countries, but regulations may vary. New countries will be added shortly; announcements will be made in due time.

About Dentsply Sirona

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering, including dental and oral health products, as well as other consumable medical devices under a strong portfolio of world-class brands. As The Dental Solutions Company™, Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better, safer and faster dental care. Dentsply Sirona’s headquarter is located in Charlotte, North Carolina. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products.

About Panthera Dental

Panthera Dental designs, manufactures and markets dental prosthetic, implantology and sleep breathing disorder solutions using a cutting-edge CAD/CAM process and superior quality materials. Both a pioneer and a leader in the field of custom-made dental solutions, our proprietary technology allows us to offer next-generation products to the widest range of patients possible. Panthera Dental is headquartered in Quebec City, Canada, with subsidiaries in the USA and France, and associates worldwide.

References

1 Park JG, J G Park, Mayo Clinic, Center for Sleep Medicine. In: Encyclopedia of Sleep. Kushida A. (Ed). Elsevier, 2013: 265-268.

2 Sutherland K, Phillips CL, Cistulli A. Efficacy vs Effectiveness: CPAP and Oral Appliances. J Dent Sleep Med 2015;2(4):175-181.

Bachour P, Bachour A, Kauppi P, Maasilta P, Mäkitie A, Palotie T. Oral appliance in sleep apnea treatment: respiratory and clinical effects and long-term adherence. Sleep Breath 2016;20(2):805-812.