Rheumatic Heart Disease

SALT LAKE CITY--(BUSINESS WIRE)-- Foldax® Inc., a pioneer in the development of innovative, polymer heart valves, today announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the TRIA™ polymer mitral surgical heart valve outside of the U.S. for the first time. The TRIA mitral valve is designed specifically to accommodate the anatomy and pressures of the mitral position. It combines the company’s proprietary polymer – LifePolymer™ – with an innovative valve design intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants. The novel LifePolymer material and computer-designed valve help to democratize the manufacturing process, minimizing the people and processes associated with animal-based tissue valve manufacturing, enabling manufacturing in any location, and improving product variability, precision, repeatability, and quality. “Our collaboration with Dolphin Life Science India LLP represents a pivotal move toward expediting the commercial release of the TRIA valve in our first targeted commercial region of India,” said Ryan Stanfield, Vice President of Engineering and Operations with Foldax, Inc. “We are honored to collaborate with Foldax to bring the TRIA valve manufacturing capability to India, with the intent of making a positive difference in the lives of millions of rheumatic heart disease (RHD) patients who can benefit from this novel polymer valve,” said Mukesh Chovatiya, Managing Director of Dolphin Life Science India. Dr. Kaushal Pandey, an investigator in the Company’s recent India clinical trial of the TRIA valve, who believes it to be the fastest-enrolling clinical trial for any surgical mitral valve, commented, “We have a pressing need in India for alternatives to tissue and mechanical valves, as current commercial offerings often fall short in durability and patient acceptance. I am encouraged to see the Company’s progress in getting one step closer to making this exciting heart valve available to Indian patients who critically need it.” The TRIA heart valve and LifePolymer technology are considered investigational and are not available for commercial sale in the U.S. or any other region. Dolphin Life Science India LLP is an expert in manufacturing medical devices. The company is registered with India’s regulatory bodies, the Drugs Controller General of India (DCGI), and the Central Drugs Standard Control Organization (CDSCO). About Foldax Foldax Inc. is a medical device company committed to reinventing every aspect of the heart valve – from material to design to manufacturing – to develop surgical and transcatheter valves designed to last a lifetime addressing historical tradeoffs. To learn more about Foldax, visit Foldax investors include Angel Physicians Fund, Biostar Capital, Caltech, Glenview Capital, Kairos Ventures, Memorial Care Innovation Fund and Sayan Bioventures. View source version on businesswire.com: Contacts MEDIA CONTACT: Michelle McAdam, Chronic Communications, Inc. michelle@chronic-comm.com (310) 902-1274 Source: Foldax Inc. View this news release online at:

As Streptococcus A cases continue to be prevalent, a new nasal vaccine could provide long-term protection from the deadly bacteria. The development of a Strep A vaccine which is currently in Phase 1 clinical trials in Canada and quickly advancing to Phase 2 efficacy trials. As Streptococcus A cases continue to be prevalent in Queensland and internationally, a new nasal vaccine could provide long-term protection from the deadly bacteria. Associate Professor Manisha Pandey, Professor Michael Good, and their team from Griffith University's Institute for Glycomics, are leading the development of a Strep A vaccine which is currently in Phase 1 clinical trials in Canada and quickly advancing to Phase 2 efficacy trials. The team's new preclinical research, recently published in Nature Communications, shows an experimental liposome-based vaccine approach incorporating a conserved M-protein epitope from Strep A and an immunostimulatory glycolipid (3D(6-acyl) PHAD) administered via the nasal passage, can provide long-term mucosal protection against Strep A. Lead author Dr Victoria Ozberk said studies have shown most pathogens enter or colonise via the soft tissue in the upper respiratory tract, which is essentially the highway to the rest of the body. "This has the potential to be a world-first as there are currently no subunit vaccines that target the upper respiratory tract due to a lack of licenced immunostimulants suitable for human use," Dr Ozberk said. "We demonstrated that a liposomal mucosal vaccination strategy can induce robust local protective immunity." Associate Professor Pandey said the team found PHAD plays an augmenting role in inducing enduring humoral and cellular immunity, which was evident for at least one-year post-vaccination. "The longevity of immune response is a critical hallmark of successful vaccination and therefore the findings from this study are highly significant," she said. Professor Good said: "In the future, this vaccine platform could pave the way for other mucosal pathogens." Group A Streptococcus is a global human pathogen that leads to a wide range of infections from illnesses such as mild pharyngitis and impetigo to invasive diseases such as toxic shock syndrome, necrotising fasciitis, and cellulitis. Professor Mark von Itzstein AO, Director of the Institute for Glycomics, welcomed these research findings. "This platform provides a real shot at developing a new direction for vaccine discovery against significant infectious pathogens that cause serious and life-threatening diseases," he said. Immunity to Strep A takes several years to develop, and currently, there is no vaccine available. Moreover, repeated infections can lead to the post-streptococcal sequelae of rheumatic fever and rheumatic heart disease, for which the Australian Indigenous population bears the highest disease burden globally. Strep A causes 700 million human infections each year and there are more than 500,000 deaths globally. The team has developed a Strep A vaccine which is currently being tested in a human clinical trial in Canada. The paper 'A Glycolipidated-liposomal peptide vaccine confers long-term mucosal protection against Streptococcus pyogenes via IL-17, macrophages and neutrophils' has been published in Nature Communications.

In a clinical validation study published on Scientific Reports, UNITY RhD NIPT and Fetal antigen NIPT demonstrated 100% sensitivity, 100% specificity, 99.9% precision with 0.1% no-call rate across 3,921 NIPT assays. MENLO PARK, CA / ACCESSWIRE / August 11, 2023 / BillionToOne, experts in fetal DNA quantification, announced today that Scientific Reports published a study1 of the UNITY Fetal Antigen Noninvasive Prenatal Test (NIPT). The validation study marks an inflection point for patients who are at risk of Hemolytic Disease of the Fetus and Newborn (HDFN) due to the assay's unmatched accuracy coupled with its novel approach. Validation of a non-invasive prenatal test for fetal RhD, C, c, E, K and Fya antigens In this validation study co-authored by scientists at BillionToOne and Brigham and Women's Hospital and senior-authored by Dr. Kathryn Gray, MD, PhD, the UNITY Fetal Antigen NIPT correctly determined the antigen status for 1,061 preclinical samples resulting in 100% sensitivity and specificity and achieved 99.9% precision on 1,683 clinical samples. Clinical samples with known outcomes (neonatal antigen genotype/serology) were also evaluated with 100% concordance across 93 antigen evaluations in 30 alloimmunized pregnancies. Impressively, 100% accuracy was achieved while maintaining a low no-call rate of 0.1%. HDFN is a serious condition that occurs when a pregnant patient's antibodies cross the placenta and attack the fetal red blood cells. When most severe, HDFN can cause life-threatening anemia in the fetus. Prior to the availability of UNITY Fetal Antigen NIPT, identifying patients at highest risk of HDFN was error-prone and cumbersome, necessitating a partner's sample and invasive diagnostic testing. This new approach with UNITY Fetal Antigen NIPT is set to revolutionize identification and management for patients at risk of severe HDFN due to the assay's greater accuracy and convenience compared to existing tests like amniocentesis, which comes with many risks, particularly for patients at risk of HDFN. The publication also highlights how UNITY Fetal Antigen NIPT can also be used to nearly eliminate unnecessary prophylactic treatment for 40% of RhD-negative pregnancies. The assay's unique capability to accurately assess non-deletion RHD gene variants, which are more prevalent in non-European populations, underscores the test's applicability and validity across ethnically diverse populations. This capability reduces the assay no-call rate to 0.1%, significantly lower than any previous RhD assays and addresses any potential concerns against front-line RhD NIPT screening. "At BillionToOne, we are uniquely positioned to do the unthinkable with genetic testing due to our QCT technology," said Oguzhan Atay, PhD, CEO of BillionToOne. "The published validation data for UNITY Fetal Antigen NIPT is a perfect example of this, ultimately setting a new standard for patients and providers in the management of HDFN." As stated in the publication, "the clinical implementation of NIPT can significantly improve the standard of care for both prevention of RhD alloimmunization and management of alloimmunization in pregnancy." About the UNITY Fetal Antigen NIPT The UNITY Fetal Antigen Test Screen was first launched in September 2022 for pregnant patients alloimmunized against RhD, C, c, E, K (Kell), and Fya (Duffy) red blood cell (RBC) antigens, and can be performed as early as 10 weeks of gestation. Using BillionToOne's proprietary molecular counting technology or Quantitative Counting TemplatesTM (QCTs), this NGS-based assay detects the presence or absence of the genetic variants that code for corresponding fetal antigens to accurately identify which patients are truly at highest risk for developing HDFN. Since its launch, over 1,000 UNITY Fetal Antigen NIPT have been ordered for clinical use. About 60% of those patients received a "Not Detected" Fetal Antigen result, sparing the expecting parents from unnecessary follow-ups and undue anxiety. About UNITY Fetal RhD NIPT The UNITY RhD NIPT was launched in 2020 for pregnant patients with RhD-negative blood type at the gestational age of 10 weeks or higher. Up to 40% of RhD-negative pregnant individuals carry an RhD-negative fetus and do not need the administration of Rho(D) immune globulin. The QCT technology-based quantitative approach with NGS enables the assay to detect fetal RhD status both for the common RHD gene deletion and other RHD variants such as RHDΨ, significantly reducing the no-call rate while maintaining 100% sensitivity and specificity. About BillionToOne Headquartered in Menlo Park, California, BillionToOne is a precision diagnostics company on a mission to make molecular diagnostics more accurate, efficient, and accessible for everyone. The company's patented QCT™ molecular counter platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level. For more information, please visit . For more information about the trial or the collaboration, please contact media@billiontoone.com. 1 Alford, B., Landry, B.P., Hou, S. et al. Validation of a non-invasive prenatal test for fetal RhD, C, c, E, K and Fya antigens. Sci Rep 13, 12786 (2023). Contact Information Courtnay Davis Events Marketing Manager media@billiontoone.com 6504602551 SOURCE: BillionToOne Inc. View source version on accesswire.com: