Phoenix-based Biolab Sciences Inc., a regenerative biotechnology company, acquired the patents and intellectual property for Myown Skin, a regenerative therapy, from Bogota, Colombia-based Keraderm. The acquisition enables Biolab Sciences to license Myown Skin internationally and bring advanced wound care options to patients globally.
Milpitas, Calif.-based Cognitivecare LLC, reported the launch of an AI platform called MIHIC that can predict risks in maternal and infant health by leveraging neural networks and advanced computing capabilities to analyze trillions of data points.
Kfar Saba Israel-based Colospan Ltd. reported that Detroit-based Henry Ford Hospital is the first U.S. institution to perform an investigational procedure using the CG-100 bypass device to assess its ability to reduce the need for stoma creation in rectal cancer patients undergoing colorectal or coloanal surgery. CG-100 is a temporary protective bypass device which is being evaluated as an investigational treatment to determine whether it can reduce the need for a diverting stoma and its related complications. Henry Ford Hospital is the only site in Michigan – and just one of 12 sites nationwide – that will be enrolling colorectal cancer patients in the clinical trial. The CG-100 has been approved for use in the EU and Israel.
Boston-based Day Zero Diagnostics Inc. received a Phase I Small Business Innovation Research award from the National Institute of Allergies and Infectious Disease of the NIH. The award will support the integration of ultra-long read genomic sequencing from Oxford Nanopore Technologies into the company’s Epixact service for rapidly detecting health care-associated infection outbreaks.
Lyon, France-based Edap Tms SA reported that the U.S. Centers for Medicare and Medicaid Services (CMS) has issued its final rules establishing a Category 1 CPT code which facilitates reimbursement for the ablation of malignant prostate tissue with HIFU technology, effective Jan. 1, 2021. On the Hospital Payment side, the final rule maintains the HIFU procedure in the Level 5 Urology Ambulatory Payment Classification in 2021. This translates into a payment for a hospital performing a HIFU procedure on a Medicare patient of around $4,500 as a national average, adjusted locally based on the wage index. This represents an increase of $256, or 6%, from the payment hospitals receive from Medicare for a HIFU procedure in 2020. In the Physician Fee Schedule final rule, CMS has established for the first time a payment to physicians performing a HIFU procedure in the U.S. In the final rule, CMS has set a total Relative Value Units (RVUs) for a physician performing a HIFU procedure at 29.09. This translates to an average payment of $943 for a urologist performing a HIFU procedure on a Medicare patient in a facility setting.
Tucson, Ariz.-based Htg Molecular Diagnostics Inc. launched an early access program (EAP) for its whole transcriptome panel using the Htg Edgeseq technology. The EAP is intended to allow select customers access to the panel in their laboratories or through services to be performed in the company’s development laboratory prior to commercial launch of the product. Htg reported the completion of proof of concept for a prototype whole transcriptome panel and demonstrated technical feasibility in November 2020. The panel is expected to allow for analysis of the entire known human transcriptome while retaining the advantages of Htg’s smaller targeted panels.
Cincinnati-based Meridian Bioscience Inc. has submitted its application for emergency use authorization to the U.S. FDA for the company’s SARS-CoV-2 molecular diagnostic test on the Revogene platform.
Mojo Vision Inc., of Saratoga, Calif., and Nagoya, Japan-based Menicon Co. Ltd. have entered a joint development agreement. The two will conduct a series of feasibility studies, with areas of collaboration identified as contact lens materials, cleaning and fitting, among other topics. If the feasibility studies prove successful, Mojo and Menicon may consider a more extensive working relationship.
Kitchener, Ontario-based O2 Industries, which manufactures reusable respirators, reported the upcoming launch of a medical-grade respirator with the safety and practical needs of healthcare workers at the forefront of its design. The launch announcement follows the receipt of a $1.8 million grant from the Government of Ontario’s Ontario Together fund.
Remedy Health Media, a Montclair N.J.-based portfolio company of Topspin Consumer Partners, reported the acquisition of Bellevue, Wash.-based Patient Power, an online consumer-focused cancer patient network providing comprehensive and dedicated resources across a variety of cancer types. No financial details were disclosed.
Basel, Switzerland-based Roche reported a partnership with Moderna Inc., of Cambridge, Mass., to utilize the Elecsys Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials. This follows the recent announcement that Roche has received emergency use authorization from the U.S. FDA for the Elecsys Anti-SARS-CoV-2 S antibody test.
Sebia, of Lisses, Île-de-France, reported a license agreement with the Erasmus University Medical Center in Rotterdam, Netherlands, and the Radboud University Medical Center in Nijmegen, Netherlands. This partnership aims to enable Sebia to develop a novel clinical laboratory test that provides minimal residual disease (MRD) status directly on serum samples. The collaboration also intends to offer a more accessible and sensitive MRD test for multiple myeloma patients and related conditions. The specific terms of the agreement have not been disclosed.
Sight Diagnostics, of Tel Aviv, Israel, reported a distribution partnership with Phoenix Capital to extend Sight’s footprint in the Middle East. Through the partnership, Sight will provide Olo analyzers to medical centers across the Middle East to help providers make quick and informed treatment decisions.
Skinopathy, a new Toronto-based medical technology startup, is developing artificial intelligence technology to help fight skin cancer.
San Diego-based Sorrento Therapeutics Inc. said that it has received CLIA licensure from California that permits testing of clinical samples. The company intends to initially focus on testing for SARS-CoV-2 infection but expects to expand to include immuno-oncology tests to support its clinical trials.
Toronto-based Vitalhub Corp. reported the additional sale of recently acquired subsidiary Intouch with Health’s Synopsis Iq solution to the expanded digital health platform installation at King’s College Hospital NHS Foundation Trust.