MedTech Industry: Commercial, Regulatory and Clinical Updates

Posted on May 20, 2021 by Delveinsight

medtech-news-updates-approvals

HCmed Signs a Global Development Agreement with CSL Behring to develop a combination product

On May 04, 2021, HCmed has announced the start of a strategic partnership with global biotherapeutics leader CSL Behring to collaboratively develop CSL Behring’s plasma-derived immunoglobulin administered via HCmed’s new generation vibrating-mesh nebulising device (CSL787)

As per the deal between the two companies, CSL Behring will have complete responsibility for developing and commercialising the combination product. HCmed leads the development of the customised nebulising device specifically optimised for CSL Behring’s formulation. Payment will be given to HCmed along with device and development milestones. It will also get royalties from global net sales of CSL Behring’s formulation for use with the combination product.

The CSL787 Phase I clinical trial has commenced, with the first subject dosed in December 2020.

Santen receives Health Canada Approval of PRESERFLOTM MicroShunt

On May 04, 2021, Santen Canada Inc., a subsidiary of Santen Pharmaceutical Co., Ltd., has received approval from Health Canada for PRESERFLO MicroShunt. This surgical device helps to drain eye fluid and reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) whose IOP is not controlled using maximum tolerated glaucoma medications.

Carol Stiff, Head of Santen Canada Inc., said that the approval for PRESERFLO MicroShunt is a significant milestone in Santen’s aim to preserve vision by bringing innovation to glaucoma surgery for patients in Canada and advances their growth in the North American market. With this approval, they are thrilled to bring the benefits of PRESERFLO MicroShunt to the Canadian market and to be able to offer a new surgical option for doctors and patients, shown to provide sustained reductions in IOP.

PRESERFLO MicroShunt is made of a proprietary, biocompatible material called SIBS [poly(styrene-block-isobutylene-block-styrene)] and is a flexible, 8.5-mm-long tube with planar fins to fixate the device in the tissue through a micro-incision and prevent leakage and migration. PRESERFLO MicroShunt is currently available in Europe.

Micro Medical Solutions Obtains FDA Breakthrough Device Designation for MicroStent Vascular Stent

On May 04, 2021, Micro Medical Solutions (MMS) has secured the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MicroStent vascular stent. This novel technology is designed to accomplish and sustain vessel patency, enhance wound treatment, and improve the quality of life and blood flow to lessen amputation and mortality for patients with chronic limb-threatening ischemia (CLTI) resulting from peripheral artery disease (PAD).

Gregory Sullivan, CEO of Micro Medical Solutions, said that the FDA Breakthrough Device Designation is an exciting step forward for MMS and for patients with CLTI that will accelerate access to MicroStent.

MMS is conducting an FDA randomised, multicenter pivotal clinical study for MicroStent, called STAND (A Clinical Evaluation of the MicroSTent PeripherAl Vascular SteNt in subjects with Arterial Disease Below the Knee) that commenced in May 2020 and will continue at up to 25 sites across the U.S. It has also initiated enrolment for the study HEAL (An All-Comers Observational Study of the MicroStent Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease).  

OncoRes Medical’s Imaging System for Breast Cancer Surgery Receives FDA Breakthrough Device Designation

On May 05, 2021, OncoRes Medical, an Australian-based company, has gained a Breakthrough Device designation from the U.S. Food and Drug Administration to advance the development of its Quantitative Micro-Elastography (QME) Imaging System. Its technology will offer real-time tumour assessment that can help surgeons accurately identify and remove cancerous tissue. This could substantially improve outcomes in breast-conserving surgery and reduce repeat operations for women with breast cancer.

OncoRes Medical CEO, Dr. Katharine Giles, told that they know facilitating detailed assessments in-cavity may improve surgical accuracy and support complete tumour removal the first time. Breakthrough Device Designation from the FDA is a strong endorsement of their technology and its potential to change, even save, lives. It proffers a more efficient regulatory and reimbursement pathway in the U.S., securing the earliest possible surgeon and patient access to the clinical and economic benefits of this world-class innovation.

OncoRes Medical is currently raising a Series B to fund ongoing product development and in vivo studies of its system.

Viome Gained FDA Approval for its Unique mRNA Technology and AI Platform to Detect Cancers

On May 06, 2021, Viome has received a Breakthrough Device designation from the Food and Drug Administration (FDA) for its proprietary mRNA analysis technology combined with its next-generation AI platform that has been developed for early detection of oral cancer and throat cancer. This technology and AI platform is a first-of-its-kind screening tool for oral cancer and throat cancer. These two life-threatening diseases are traditionally diagnosed manually by a primary care clinician by visual or tactile senses in a subjective way and are often undiagnosed.

It analyses through saliva for the presence of Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Cancer (OPC). It has used unique mRNA analysis technology and breakthrough machine learning techniques to accurately discover the interactions between microbial activities and human gene expression in the progression of these cancers.

This approval from the FDA authenticates Viome’s mRNA analysis technology and state-of-the-art AI platform that powers Viome’s at-home Health Intelligence Test to provide consumers with deeper health insights about their gut microbiome health, cellular health, immune system health, stress response, and even biological ageing. The AI platform assesses every individual’s unique microbial and human gene expressions to deliver them with personalised food recommendations and tailor-made, precision supplements designed to address the root cause of low-grade inflammation and improve these health metrics over time.

Bigfoot Biomedical® Gains FDA Clearance for Bigfoot Unity™ Diabetes Management System, Presenting First-of-its-Kind Smart Pen Caps for Insulin Pens for Type 1 and Type 2 Diabetes Treatment 

On May 10, 2021, Bigfoot Biomedical has received 510(k) clearance from the FDA for the first-of-its-kind Bigfoot Unity™ Diabetes Management System, which presents connected smartpen caps that recommend insulin doses for people using multiple daily injection (MDI) therapy. The Bigfoot Unity smartpen caps offer on-demand insulin dose decision support to minimise guesswork and let patients follow their doctor’s instructions in a convenient, simple way. 

It is the first and only solution for people with Type 1 diabetes or Types 2 diabetes on MDI therapy, which directly utilises integrated continuous glucose monitoring system (iCGM) data from Abbott’s FreeStyle Libre 2 system to deliver an insulin dose recommendation, which is based on a physician’s instructions. The smart cap displays the dose directly for the person’s disposable insulin pens without manually inputting glucose data on a separate device. It can be used by individuals older than age 12.

Jeffrey Brewer, CEO of Bigfoot Biomedical said in a statement that diabetes management is incredibly hard because insulin has no fixed dose or timing, leaving individuals to continuously determine their doses and configure devices. At Bigfoot, Brewer intends to ease the burden of diabetes for people taking insulin by decreasing the anxious guesswork involved with insulin dosing in a convenient, simple way.

BD to Spin-Off Diabetes Care Business to Improve Focus on Innovation and Priority Growth Markets

On May 06, 2021, Becton, Dickinson, and Company (BD) has announced its board of directors has authorised the management to continue with a plan to spin off the company’s Diabetes Care business as an independent, publicly-traded to provide consumers with the company (“NewCo”). This spinoff is expected to be completed in the first half of the calendar year 2022. 

This is in line with BD’s strong ongoing commitment to its BD 2025 strategy that comprises its three main pillars of Grow, Simplify and Empower.

The decision to spin off their Diabetes Care business is part of the active portfolio management and consistent with the BD 2025 strategy. The spinoff will let BD strengthen its growth profile, allow a greater investment focus on their other core businesses and high-growth opportunities, and significantly impact the customers and patients as per Tom Polen, chairman, CEO, and president of BD.

After the spinoff, BD will maintain category leadership positions across its portfolio in the BD Medical, BD Life Sciences, and BD Interventional segments. At the same time, NewCo will be better positioned to continue its strategic priorities, build on its recent leadership positions in the diabetes care market, and attract new investors. 

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