BioNTech to Ship Modular mRNA Vaccine Factory to Rwanda

Biopharmaceutical New Technologies (BioNTech), the global immunotherapy company based in Mainz, Germany, is scheduled to ship its BioNTainer modular mRNA vaccine factory to Rwanda.  According to BioNTech’s press release, the modular factory consists of six ISO-sized shipping containers that will arrive in Rwanda sometime in early 2023.  Reports indicate that the modular units were manufactured in Germany and will be filled and finished by local partners in Ghana and South Africa.

According to reports, this modular mRNA vaccine factory will allow for the bulk production of BioNTech’s COVID-19 vaccine in areas with limited technological resources.  Each modular factory “is expected to produce 50 million COVID vaccine doses per year” that will be sold on a not-for-profit basis.  BioNTech expects completion of this modular vaccine factory to proceed in parallel with construction of a “state-of-the-art manufacturing facility in Kigali, Rwanda,” which broke ground in June 2022.  Additional BioNTainer factories may be shipped to Senegal and South Africa in the near future.  BioNTech’s press release explains that these modular vaccine factories are intended to become part of a network to provide African nations with access to its COVID-19 vaccine.

In addition to its COVID-19 vaccine, BioNTech is reportedly “advancing mRNA-based vaccine candidates to address malaria and tuberculosis.”  BioNTech initiated early-stage in-human studies for a malaria vaccine candidate in December 2022, and expects additional vaccine candidates to start in-human trials in “early 2023.”

Cochlear Implant Developer Agrees to Pay for Alleged False Claims to FDA

Cochlear implant developer Advanced Bionics LLC will pay about $12 million to resolve allegations that it misled federal health care programs, the United States Department of Justice (DOJ) announced.  The allegations were in connection with information provided within pre-market approval (PMA) applications to the FDA for cochlear implant processors, as reported by a DOJ press release dated December 20, 2022.

A former Advanced Bionics engineer, David Nyberg, brought a lawsuit against Advanced Bionics under the False Claims Act. The lawsuit asserted that Advanced Bionics made false claims in their PMA submissions to the Food and Drug Administration (FDA) for Advanced Bionics’ Neptune and Naida cochlear implant processors. Advanced Bionics allegedly made false assertions in the PMA submissions stating that the processors complied with a recognized emissions standard when the processors, in fact, did not comply with the standards.

As a result of the agreement, Advanced Bionics will pay roughly $11.36 million to the United States with approximately $1.87 million of the amount being paid to Mr. Nyber.  Advanced Bionics will also pay approximately $1.24 million to the participating Medicaid States pursuant to additional agreements.

BIOCORP Receives FDA 510(k) Clearance for Smart Injection Sensor

French medical device company BIOCORP announced in a press release that it received FDA 510(k) clearance for Mallya, a device that according to the company allows insulin pen injectors to capture and transmit injection data such as dose, date, and time of injection to a mobile app via Bluetooth.

According to the Mallya website, the device allows users to keep track of their doses as well as share dosage information with family members and medical professionals.  BIOCORP offers three models of the Mallya, one for each type of disposable insulin pen.  The device, shown below on a pen, comes in two pieces that clip on to the insulin pen and can be removed and reused with new pens.

Mallya

Mallya first launched in France on April 13, 2021.  Since then, it has expanded to several countries, including Japan, Nambia, Netherlands, Romania, South Africa, and Taiwan.

On the recent FDA clearance, Eric Dessertenne, CEO of BIOCORP, commented:

This approval is a major achievement for BIOCORP and all of our employees who have been heavily involved in this regulatory process.  This approval marks a historic achievement for BIOCORP as it allows the commercial launch of our Mallya device in the United States and illustrates BIOCORP’s ability to meet the highest regulatory requirements.

Other companies have also expressed interest in integrating insulin technology with Mallya.  In March, Diabeloop, a company focused on artificial intelligence-driven insulin systems, announced a partnership with BIOCORP to integrate Mallya into Diabeloop’s automated insulin pumps.

The full BIOCORP press release can be found here.

Developments in Patent Disputes Between Apple and AliveCor

Earlier this year, AliveCor, Inc., a medical device and AI company producing electrocardiogram (ECG) hardware and software for consumer mobile devices, succeeded in convincing an International Trade Commission (ITC) judge that Apple Inc. infringed multiple, valid claims of three AliveCor patents on ECG technology.  By December 12, 2022, the full ITC is expected to issue a final decision in that investigation (337-TA-1266).

With the final ITC decision just days away, Apple filed suit against AliveCor, Inc. in the Northern District of California on December 2.  Apple alleges that the ECG functionality of several AliveCor products, including KardiaMobile, KardiaMobile 6L (pictured below), KardioMobile Card, and the related Kardia App, infringe one or two Apple patents: U.S. Patent Nos. 10,076,257 and 10,866,619.  Apple also alleges that AliveCor’s KardiaPro service and Kardia App, in conjunction with various Kardia devices, infringe one or two additional patents: U.S. Patent Nos. 10,270,898 (titled “Wellness Aggregator”) and 10,568,533 (titled “User Interfaces for Health Monitoring”).

Less than a week after Apple filed suit, a panel of Patent Trial and Appeal Board (PTAB) administrative judges found that the three AliveCor patents asserted in the ITC investigation were invalid.  According to Law360, an AliveCor spokesperson explained AliveCor is “deeply disappointed and strongly disagrees with the decision by the PTAB and will appeal.”  Regarding whether the PTAB’s findings should impact the ITC’s decision, the AliveCor’s spokesperson added:

The PTAB and ITC are two, separate independent bodies and will make their own separate independent decisions. We look forward to the separate final determination from the ITC expected December 12 and are cautiously optimistic.

J&J Acquires Abiomed for $16.6 Billion

Johnson & Johnson (“J&J”) announced on November 1, 2022, that it will acquire Abiomed for an upfront payment of $380.00 per share in cash, which equates to about $16.6 billion.  The acquisition is expected to be completed in the first quarter of 2023.  According to reports, after the acquisition, Abiomed “will operate as a standalone business within J&J within Johnson & Johnson MedTech, becoming one of the company’s dozen ‘priority platforms,’ defined by annual sales of at least $1 billion.”

Joaquin Duato, Chief Executive Officer of Johnson & Johnson, stated that “[t]he addition of Abiomed is an important step in the execution of our strategic priorities and our vision for the new Johnson & Johnson focused on Pharmaceutical and MedTech,” and he further stated the acquisition will continue to enhance J&J’s “position in MedTech by entering high-growth segments. The addition of Abiomed provides a strategic platform to advance breakthrough treatments in cardiovascular disease and helps more patients around the world while driving value for our shareholders.”  The acquisition follows reports earlier this year that J&J intended to “get active on the medtech M&A front.”

Abiomed was founded in 1981 “for the purpose of developing the world’s first artificial heart. ”  Abiomed currently makes the Impella heart pump, which is “a support system of percutaneous catheter-based technology offering hemodynamic support to the heart.”  Abiomed also offers the Breathe OXY-1 System, which is a “cardiopulmonary support system with an integrated oxygen concentrator.”  Last year, Abiomed acquired the start-up preCARDIA and its catheter technology.  Recently, “Abiomed reported revenue of $266 million, up 7% and up 11% in constant currency year over year, the seventh consecutive quarter the company posted double-digit revenue growth in constant currency.”

The press release may be accessed here.

Report: Medical Device Market Expected to Grow Over Next Seven Years

An article from October 2022 states that the global medical device market is projected to jump by seven billion dollars in 2022 and leap to $223 billion over the next seven years, to reach a valuation of around $719 billion by 2029. A report by consulting firm Fortune Business Insights anticipates a 5.5% compound annual growth rate (CAGR) over this period.

The report identifies several factors contributing to the industry’s growth.  These factors include a global rise in prevalence of chronic diseases, increased healthcare spending in developed and emerging countries, and a new emphasis on early detection and treatment by healthcare agencies.  This is reported to be resulting in more and more patients undergoing diagnostic and surgical procedures.

According to AdvaMed, the U.S. occupies about 40% of the global medical device market. In segmenting the U.S. market share, Fortune Business Insights found that in-vitro diagnostics (IVD), cardiovascular devices and orthopedic devices are the largest segments.  The report expects the IVD segment will grow at a higher CAGR due to the increased use of real-time diagnostics tests for the diagnosis of diabetes, cancer, and HIV/AIDS. The report also notes an uptick in the market for portable and wearable devices for treatment of chronic conditions due to a shift in preference among the elderly for home healthcare services following the COVID-19 pandemic.

The report also states the European market is anticipated to grow at an increased CAGR, due to the region’s increased spending on healthcare, well-established infrastructure, and increased adoption of advanced diagnostic devices. As with the U.S., Europe is reported to have seen a shift in focus to at-home medical care that suggests portable equipment will play a large role in their anticipated market growth.

Increased prevalence of cardiovascular disorders, diabetes, infectious disorders and dental diseases are all demand factors contributing to the forecasted growth in Asia Pacific, according to the report, causing more global medical device players to expand their presence in the region.

The three top-earning medical device companies globally in 2021 – Medtronic, Abbott, and Johnson & Johnson – are among those companies set to benefit highly from the industry’s predicted growth. However, the increasing demand for the medical device market as a whole guarantees that the future is looking bright for many companies in the space.

The report by Fortune Business Insights is available here.

FDA Grants Breakthrough Device Designation for EndoStim’s GERD Treatment

EndoStim announced on October 25th that the FDA granted a breakthrough device designation for the company’s implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD).

EndoStim states that its EndoStim System is the first-in-class implantable neurostimulation treatment for GERD. While traditional surgery for the treatment of GERD requires wrapping the stomach around the lower esophagus to strengthen a patient’s lower esophageal sphincter muscle (LES), this system attempts to provide long-term reflux suppression by automatically delivering small electrical signals to the LES. EndoStim states the system accomplishes this through use of a neurostimulator and an implantable bipolar lead, and that the lead is placed within the patient through a minimally invasive laparoscopic procedure, and a physician then programs the neurostimulator using a wireless external programmer.

While the EndoStim System is not yet approved for sale in the U.S., multiple long-term studies, such as a University of Vienna study and a German study, on electrical implants aiding GERD using this system have been reported to have found a sustained improvement in GERD outcomes post-procedure. In discussing the announcement, EndoStim’s chief executive officer, Eric Goorno, stated:

We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD.… Our goal is to bring this new therapy to patients as quickly as possible. We look forward to working closely with the FDA to expedite the review of the EndoStim System.

The breakthrough device designation program is designed to provide patients and health care providers with timely access to medical devices for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by speeding up their development, assessment, and review. The FDA recently updated its draft guidance for its breakthrough device designation program to focus on reducing health and healthcare disparities based on race, sec, ethnicity, and access to care.

This year it is reported that the FDA granted 120 breakthrough device designations through August 3, 2022. Since the program’s inception in 2015, the breakthrough device designation program is reported to have seen 54 devices receive marketing authorization.

FDA Approves LimaCorporate’s 3D-Printed Reverse Shoulder Replacement System

The FDA recently approved LimaCorporate’s fully 3D-printed glenoid baseplate and humeral stem for use in reverse shoulder replacement.

The shoulder includes the glenohumeral joint, which is the ball-and-socket joint where the head of the humerus (i.e., the ball) joins the glenoid (i.e., the shoulder socket in the scapula).  However, when the associated tendons are damaged, reverse shoulder replacement or arthroplasty may be used to repair the joint.  In reverse shoulder replacement, the ball and socket of the glenohumeral joint are replaced in opposite positions.  As such, the ball is placed on the socket side of the joint and the socket is placed on the ball (i.e., arm) side where it is typically supported by a stem that is implanted in the humerus.  LimaCorporate reports that its new PRIMA TT Glenoid system includes a 3D-printed convertible short stem and a fully 3D-printed glenoid replacement for Reverse Shoulder Arthroplasty.

According to a press release, LimaCorporate’s PRIMA TT Glenoid system uses trabecular titanium (TT), which is lightweight biomaterial containing titanium and having a regular three-dimensional hexagonal cell structure that imitates trabecular bone morphology, which is designed to encourage strong primary fixation and secondary bone ingrowth.  In response to the FDA’s approval of the PRIMA TT Glenoid system, LimaCorporate’s CEO Massimo Calafiore stated “Today’s FDA approval for PRIMA TT Glenoid represents an exciting opportunity to accelerate our market growth in key regions. The new PRIMA shoulder platform will support our surgeons to bring the emotion of motion to even more patients!”

LimaCorporate states it is planning to launch the PRIMA TT Glenoid shoulder replacement system in 2023.

Cambridge Cognition Acquires eClinicalHealth, Targets Improved Virtual Clinical Trial Offerings

Cambridge Cognition Holdings PLC announced on October 12, 2022 that it acquired eClinicalHealth Ltd. (eCH) for about $1.9 million. eCH offers the Clinpal platform, which facilitates virtual clinical studies. Per the announcement, Cambridge Cognition acquired eCH to “enhance” Cambridge Cognition’s capabilities within the virtual clinical study space. According to Cambridge Cognition, the addition of eCH allows coverage of “all modules from recruitment through to clinical reporting.”

Founded in 2012, eCH is a digital technology provider. eCH’s Clinpal is an end-to-end clinical study platform. Clinpal allows researchers to configure a study, market to and recruit potential study patients, gather data from enrolled patients, and store and access study data. According to eCH, several studies involving a “top 10 pharma” company have already used Clinpal.

Cambridge CognitionCambridge Cognition is a tech company that develops digital solutions for clinical cognitive studies. More specifically, the company offers several different digital platforms intended for use at various stages of a clinical study, such as patient recruitment, study design, and data analysis. According to Cambridge Cognition, virtual clinical study is suitable for many different central nervous system disorders—for example, depression or Alzheimer’s disease. Such studies can run regular cognitive assessments at home. In this vein, Cambridge Cognition’s CANTAB platform enables remote assessment. CANTAB can administer cognitive tests to a patient via a mobile device.

Zooming out, the expansion of the virtual clinical trial market may have been accelerated by the COVID-19 pandemic. As of 2022, 89% of clinical study sponsors use decentralized technologies and methods in their studies.

FDA to Collaborate with Veterans group on Medical Device Innovation

On September 28, 2022 the FDA announced a collaboration with the Veterans Health Administration (VHA), in particular the VA Ventures Innovation Institute. According to the FDA, the intent of the collaboration is to “help accelerate American medical device innovation to further improve and benefit public health. One goal of the collaboration is providing innovators with “straightforward, reproducible, and cost-effective testing methods throughout the product development cycle.”

Jeff Shuren, M.D., J.D., the director of the FDA’s Center for Devices and Radiological Health stated in the FDA’s announcement of the collaboration that:

This strategic alignment between our organizations creates a unique environment to achieve shared objectives for accelerating patient access to safe, innovative and effective medical devices.

The VHA will host staff from the FDA at the VA Ventures Innovation Institute in Seattle. According to the announcement, the FDA staff will be focused on the regulatory science while the VA staff will provide “clinical context for test development and provide hands-on training and other immersive experiences.”

The initial collaboration is described by the FDA as focusing on systems which can “exchange health information automatically for the diagnosis and treatment of patients.” While future areas of collaboration may include “the development of test methods for devices that can be used at a distance through, for example, 5G networks.”

Dr. Shereef Elnahal, the VA’s Under Secretary for Health, stated in the FDA announcement:

By working side by side, VA and FDA will leverage our combined strengths and expertise to bring the most promising health care technology innovation to Veterans – and Americans at large – faster than before.

The announcement by the FDA is available here.

 

 

 

 

 

 

 

 

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