January 16, 2018
Foundation Medicine and Pfizer Announce Partnership
Foundation Medicine announced that the company has entered into a broad partnership with Pfizer. The partnership focuses on development, regulatory support and commercialization of companion diagnostics (CDx) that will be included in updates to FoundationOne CDx. FoundationOne CDx is Foundation Medicine's FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that incorporates multiple companion diagnostics. Pfizer will also benefit from access to FoundationInsights, Foundation Medicine's data analytics platform, to facilitate novel biomarker discovery and to optimize clinical trial design. The combination of FoundationInsights and FoundationOne CDx will potentially enable Pfizer to leverage Foundation Medicine's platform technology to accelerate discovery and development of precision oncology therapeutics.
Pfizer currently has 10 FDA-approved oncology medicines that treat a diverse array of solid tumors and hematologic malignancies. In addition, its oncology pipeline includes 17 assets in clinical development and 19 phase 3 studies.
FoundationOne CDx assesses all classes of genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It also reports genomic biomarkers, such as microsatellite instability (MSI) and tumor mutational burden (TMB), that can help inform the use of immunotherapies; genomic alterations in other genes relevant to patient management; and relevant clinical trial information. As such, it is designed to help streamline companion diagnostic development, mitigate risk and advance targeted therapy development. Currently FoundationOne CDx is FDA-approved as a CGP assay for all solid tumors and a broad companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies.
Concurrent with FDA approval, the Centers for Medicare & Medicaid Services (CMS) issued a preliminary National Coverage Determination (NCD) for FoundationOne CDx. The draft NCD would provide coverage for FDA-approved companion diagnostic claims, as well as a pathway for additional coverage with evidence development in other solid tumor types. The final policy is expected to issue during the first quarter of 2018 following public comment on the preliminary NCD and an administrative period.
See more about FoundationOne on Meddevicetracker. As this product is a companion diagnostic, the full development history of the associated drugs can be seen on Biomedtracker.
RepliCel Signs Investment Partnership with YOFOTO Health
RepliCel Life Sciences announced it has signed a Binding Term Sheet (the Term Sheet) with YOFOTO (China) Health Industry to form a strategic partnership (the Transaction) in Greater China (Mainland China, Hong Kong, Macau, and Taiwan) (the Territory).
The deal reflected in the Term Sheet, involves an up-front investment of USD $6,500,000 and potential pre-commercial, non-dilutive milestones payments of another USD $2,800,000. Additionally, the Term Sheet commits YOFOTO to another USD $1,000,000 in potential post-commercial non-dilutive milestone payments, several million in dedicated program funding in Greater China over the next five years, and future royalty payments calculated on gross product sales in the Territory.
The investment is by way of the purchase of common shares (each, a Share) at CDN$0.54 per Share, which is a premium over the 20-day average market price to reflect the accompanying license to YOFOTO in the Term Sheet. The Company has also agreed to issue share purchase warrants (each, a Warrant) equal to 10% of the number of Shares issued, which warrants will be exercisable at CDN$0.54 per Share for a period of two years.
YOFOTO has already paid a deposit of USD $650,000 (the Deposit) pursuant to the agreement. As part of the Transaction, YOFOTO will receive an exclusive license for RepliCel’s tendon regeneration cell therapy (RCT-01) in development, skin rejuvenation cell therapy (RCS-01) in development, and its injection technology in development for dermal applications (RCI-02) (excluding hair-related treatments) for the Territory.
In 2013, RepliCel executed a co-development and license agreement with Shiseido Company, which covered all of Asia for its product (RCH-01) in development for the treatment of androgenetic alopecia. With the completion of the YOFOTO deal, RepliCel’s current technologies will be fully licensed in Greater China.
RepliCel maintains exclusivity over its entire portfolio outside of Asia. The Company is pursuing both its own continued development and commercialization of its assets as well as other collaborative partnerships for its programs in different regions of the world.
As part of the Transaction, the Company has agreed to grant YOFOTO certain financing participation rights and board seat nominations and YOFOTO has agreed to certain voting and trading restrictions. Closing of the Transaction is subject to execution of definitive agreements for the Transaction, receipt of approval of the TSX Venture Exchange, the Company’s shareholders and other applicable regulatory authorities including but not limited to the reviews and approvals by State Administration of Foreign Exchange of China and other Chinese foreign investment regulatory authorities.
See more about the RCI-02 Dermal Injector on Meddevicetracker. As this is a combination product, the full clinical and regulatory history of RCH-01 can be seen on Biomedtracker.
January 17, 2018
DarioHealth Introduces New Smart Glucose Meter in Australia
DarioHealth announced it has launched the Lightning-enabled version of the Dario Blood Glucose Monitoring System in the Australian market. The Lightning-enabled device ensures that Apple consumers in Australia will be able to connect the Dario smart glucose meter to the latest iOS handsets, including the iPhone X.
DarioHealth received Therapeutic Goods Administration (TGA) approval for the Lightning-enabled device in Australia in December 2017.
The Australian market is the second market in January 2018 to receive the Dario Lightning-enabled device, after DarioHealth launched the Lightning-enabled device in the U.K. Germany is the next market expected to launch the the Dario Smart Glucose Meter for iPhone 7, iPhone 8, and iPhone X.
In the U.S. market, the Dario Lightning-enabled device is still under review by the U.S. Food and Drug Administration (F.D.A.), and the Company expects to hear about possible clearance in the coming months.
See more about the Dario Smart Meter on Meddevicetracker.
NeuroMetrix and GlaxoSmithKline Announce Collaboration
NeuroMetrix announced a collaboration with GlaxoSmithKline (GSK) involving Quell Wearable Pain Relief Technology.
The key elements of the collaboration are as follows:
- GSK Consumer Healthcare acquires exclusive ownership of Quell technology for markets outside the U.S.
- NeuroMetrix retains exclusive ownership of Quell technology in the U.S. market.
- GSK Consumer Healthcare and NeuroMetrix to co-fund development of Quell technology for a three-year period beginning in 2018 through 2020, with subsequent annual renewals by mutual agreement.
- GSK Consumer Healthcare to pay NeuroMetrix $5M for the assets relating to Quell technology for markets outside the U.S and up to $21.5M, upon the achievement of certain development and commercialization milestones.
See more about Quell on Meddevicetracker.
January 18, 2018
Kephalios Implants First Patient with Kalios Device
Kephalios announced that Kalios, the company’s balloon-adjustable mitral ring aimed at correcting mitral regurgitation (MR), was successfully implanted for the first time in a MR patient on January 1st, 2018 at the Vienna General Hospital (AKH), in Austria.
The patient is one of five scheduled to receive the device as part of “OPTIMISE,” a first-in-human trial designed to test the feasibility and surgical safety of Kalios. The first results are expected in the second quarter of 2018.
Intended for patients suffering from MR, Kalios is based on a proprietary annuloplasty technology, aimed at personalizing MR’s surgical treatment. Drawing on the proven implant technique of “Carpentier” rings, Kalios’ size and shape can be adjusted multiple times within months following the surgery, through minimally invasive interventions, as a way to optimize the mitral valve repair, while protecting the ventricular function.
See more about Kalios on Meddevicetracker.
Bluegrass Vascular Announces First Patient Enrollment
Bluegrass Vascular Technologies announced the enrollment of its first patients in the SAVE-US (Surfacer System to Facilitate Access in VEnous Occlusions – United States) pivotal trial. The SAVE-US clinical trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the Surfacer Inside-Out Access Catheter System to facilitate reliable upper body central venous access suitable for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods. Thirty patients will be enrolled at up to 10 centers in the United States with additional centers in Europe.
Initial patient enrollments were performed by Interventional Radiologists Chris Loh, MD, and Mahmood Razavi, MD, at St. Joseph Hospital in Orange, California and by Eric Peden, MD, a Vascular Surgeon at Houston Methodist Hospital in Houston, Texas.
Bluegrass Vascular secured CE Mark approval of the Surfacer System in 2016 and is currently enrolling patients in its post-market SAVE Registry in Europe. The Surfacer System is distributed in Europe by Merit Medical, a company dedicated to developing and commercializing lifesaving devices and methods that address shortcomings in vascular access procedures.
See more about the Surfacer Inside-Out Access Catheter System on Meddevicetracker.
January 19, 2018
Grünenthal Receives CE Certification for MAR-CUTIS
Grünenthal announced that Adhesys Medical, a wholly-owned subsidiary of the Grünenthal Group, has received CE-Certification for MAR-CUTIS (Flix). Flix is a topical skin adhesive for surgical use and the first product from Grünenthal’s pipeline of surgical sealants.
Grünenthal acquired Adhesys Medical GmbH and its US affiliate, a medical device start-up, in April 2017 and holds the worldwide development and commercialization rights for a pipeline of surgical sealants and the underlying technology platform. The polyurethane-based technology is unique, as it comes with a combination of features such as bonding strength, fast sealing and flexibility. The products based on this technology may therefore serve a wide variety of surgical procedures, including sealing in wet environments and allow Grünenthal to tap into the global surgical sealants market.
See more about CUTIS on Meddevicetracker.