Abiogenix LLC, of San Francisco, and Oakland, Calif.-based Fathom have partnered to bridge the spiral nasopharyngeal (NP) swab test kit shortage. Over 150 NP swab designs were evaluated in a clinical trial by Harvard's Beth Israel Deaconess Medical Center (BIDMC). The Abiogenix spiral design, made by Fathom using Multi Jet Fusion 3D printing technology, was selected as the preferred 3D printed swab by clinicians and patients alike. The swabs are now readily available to the medical industry and testing centers around the country. Fathom will have the ability to scale production of testing swabs from 100,000 to millions.
Alume Biosciences Inc., of La Jolla, Calif., received a "Study May Proceed" letter from the US FDA related to its recently filed investigational new drug (IND) application for the use of ALM-488 in head and neck surgery. ALM-488 is an intravenously administered peptide-dye conjugate for fluorescence highlighting of nerves during surgery. The IND was approved by the FDA Division of Medical Imaging and Radiation Medicine, which is responsible for drug products used in the image-based diagnosis and monitoring of diseases. The phase 1/2 trial of ALM-488 is a dose-escalation study in up to 36 patients undergoing head and neck surgery. Specific study cohorts will also examine ALM-488 dose timing ahead of surgery to determine effect on fluorescence nerve labeling. The primary objective of the trial is safety, and secondary objectives include determining the pharmacokinetics (PK) of ALM-488, observing efficacy as defined by dose at which optimal fluorescence signal is observed, and evaluation of the effect of dose timing relative to surgery on optimal fluorescence imaging characteristics. Alume anticipates trial initiation in Q2 2020.
Caledonia, Mich.-based Aspen Surgical Products Inc., a provider of surgical disposable products, announced the acquisition of Arden, N.C.-based Precept Medical Products Inc. Precept makes nonwoven, single-use disposable protective medical apparel that addresses infection control challenges faced by health care professionals, with a strong emphasis on the U.S. market.
San Diego-based Global Institute of Stem Cell Therapy and Research (GIOSTAR) received an approval for a COVID-19 clinical trial, led by their Medical Director Prabhat Soni. GIOSTAR will conduct the trial using stem cells to treat COVID-19 patients, under the approval of the U.S FDA. expanded access for compassionate use program. The Institute is exploring an alternative approach to the devastating disorder, which leverages the anti-inflammatory properties of mesenchymal stem cells (MSCs). According to Soni, the investigation is based upon two decades of stem cell research by GIOSTAR Co-Founder, Chairman and Chief Scientific Officer Anand Srivastava. Srivastava and Soni are seeking to leverage and apply extensive research demonstrating the effectiveness of MSCs in combating the respiratory symptoms and cytokine storms associated with COVID-19.
New York-based Kryon Systems has deployed its Full-Cycle Automation solution with the information systems and digital division at Clait Health Services, of Tel Aviv. The robotic process automation technology speeds the uploading of COVID-19 test results to Clait’s centralized database from eight separate laboratories in Israel.
Launchpad Medical Inc., of Lowell, Mass., won a grant from the National Institutes of Health’s Helping to End Addiction Long-term (NIH HEAL) initiative to improve strategies for reducing opioid misuse and addiction. The Phase 1 Small Business Innovation Research grant will advance development of the company’s dental bone graft formulation that includes the release of non-opioid pain medications following wisdom tooth extraction. the size of the grant was not disclosed.
Mediwound Ltd., of Yavne, Israel, said it is expanding its Nexobrid European presence with new distribution agreements. The company has granted Geneva-based Genfa Medica SA, its distributor in Russia, Ukraine and the Baltic countries, exclusive rights to market and distribute Nexobrid in France and Switzerland. Specialty Therapeutics pc, of Athens, has exclusive rights to market and distribute the wound debridement product in Greece, Bulgaria, Malta and Cyprus.
Richmond, B.C.-based Neovasc Inc. received an extension, through Aug. 17, 2020, to provide evidence of compliance with the $35 million minimum market value of listed securities requirement for continued listing on the Nasdaq Capital Market. The noncompliance issue does not affect the company’s status with the Toronto Stock Exchange.
Venus Medtech Inc., of Hangzhou, China, and Atlanta-based Opus Medical Therapies LLC are teaming up to develop transcatheter mitral valve replacement (TMVR) and transcatheter tricuspid valve replacement (TTVR) products in the greater China market. This all-valves solution is unavailable in any other market or from any other company, the partners said.