Medtronic’s Intellis and Vanta Neurostimulators Receive FDA Approval for DPN

Medtronic  announced that its Intellis™ neurostimulator and the Vanta™ neurostimulator have both received approval from the U.S. Food and Drug Administration (FDA) for the treatment of chronic pain associated with diabetic peripheral neuropathy (DPN), in a January 24, 2022 press release. The approval grants patients suffering from DPN access to both products within Medtronic’s spinal cord stimulation (SCS) portfolio.  The IntellisTM neurostimulator is rechargeable whereas the VantaTM neurostimulator is recharge-free .

DPN, also referred to also as painful diabetic neuropathy (PDN), is a neurological disorder that impacts about 30% of individuals with diabetes, according to the press release. DPN occurs when high blood sugar levels damage nerves causing numbness, burning, or stabbing pain. Charlie Covert, a Medtronic vice president and general manager, views the new approvals as another example of Medtronic’s expertise:

DPN is a significant challenge for patients with diabetes, leading to disability and a diminished quality of life . . . This new indication enables us to apply Medtronic’s more than 40 years of proven SCS experience, as well as the company’s deep diabetes expertise, to deliver better care to even greater numbers of diabetes patients

According to the press release, Medtronic estimates that the US market revenue for SCS treatment of chronic pain associated with DPN is approximately $70 million and expects market revenue to grow to $300 million by fiscal year 2026.

With the new approval, Medtronic’s IntellisTM and VantaTM neurostimulator products now join Nevro’s HFXTM for PDN as the only SCS devices with FDA approval for treatment of DPN/PDN. Nevro’s Chairman, CEO, and President, D. Keith Grossman, responded to the FDA’s approval of the IntellisTM and VantaTM neurostimulators in a press release, stating:

PDN represents a very large potential market, and having another competitor validate this large opportunity speaks to its attractiveness.

Nevro announced the FDA’s approval of its HFXTM on July 19, 2021.

First-in-Human Porcine Heart Transplant Performed

Surgeons at the University of Maryland School of Medicine performed the first successful porcine (pig) to human heart transplant, a procedure referred to as “xenotransplantation.”  The patient, 57 year old David Bennett, was recovering and doing well three days after the procedure.  The surgical team continues to monitor Mr. Bennett’s condition.

According to Bartley P. Griffith MD, a member of the surgical team that performed the xenotransplantation:

This was a breakthrough surgery and brings us one step closer to solving the organ shortage crisis. There are simply not enough donor human hearts available to meet the long list of potential recipients.  We are proceeding cautiously, but we are also optimistic that this first-in-the-world surgery will provide an important new option for patients in the future.

According to organdonor.gov, “about 110,000 Americans are currently waiting for an organ transplant, and more than 6,000 patients die each year before getting one.”

The surgical team spent years refining the technique in primate studies, waiting until they saw good survival over 9-12 months without organ rejection and low infection incidence before applying for the compassionate use exemption from the FDA that allowed Mr. Bennett to receive the xenotransplantation, according to surgical team member Christine Lau MD.

The donor heart was provided by Revivicor (acquired by United Therapeutics in 2011).  Ten genes in the donor heart were genetically modified, primarily to reduce the chance that Mr. Bennett’s body would reject the donor organ.

This is the second xenotransplanted organ provided by Revivicor in the last six months.  In October 2021, surgeons at New York University attached Revivicor’s genetically modified porcine kidney to the blood vessels of a brain dead patient on life support without any signs of rejection for over two days.  The xenotransplanted kidney functioned normally during that time period.

According to the University of Maryland School of Medicine’s press release, xenotransplants were first tried in the 1980s.  However, they fell out of favor after a xenotransplantation of a baboon heart into an infant in California failed due to the immune system’s rejection of a foreign heart.  In contrast, xenograft porcine heart valves have been used as valve replacements in humans for over 50 years, and xenograft valve replacements are still in use today.

This video includes more information about Mr. Bennett’s procedure and is available from the University of Maryland School of Medicine.

Acquisition of BK Medical Expands GE Healthcare’s Precision Health Presence

GE Healthcare announced on December 21, 2021, that it has completed the $1.45 billion acquisition of BK Medical from Altaris Capital Partners.  According to the press release, the acquisition expands GE Healthcare’s $3 billion ultrasound business from diagnostics into surgical and therapeutic interventions and adds to GE Healthcare’s capability in the fast-growing advanced surgical visualization segment. The acquisition further boosts GE Healthcare’s presence within the field of precision health, which refers to the tailoring of treatments to patients based on their medical histories, genetic makeup, and other factors and has a market that is valued in the tens of billions of dollars based on an article published on GE Healthcare’s website.

BK Medical is a global intraoperative imaging and surgical navigation company headquartered in Boston and Copenhagen.  Through its ultrasound technology and software algorithms, BK Medical enables surgeons to make real-time, data-based decisions during surgical procedures, including applications in general surgery, neurosurgery and spine, robotic-assisted surgery, colorectal surgery and urology.  BK Medical has more than 650 employees and has protected its technology with more than 136 patent families.

When the deal was first announced in September 2021, GE Healthcare’s President and CEO, Kieran Murphy, emphasized:

Ultrasound today forms an integral part of many care pathways, and BK Medical is a strategic and highly complementary addition to our growing and profitable Ultrasound business. This transaction helps GE Healthcare continue to expand beyond diagnostics into surgical and therapeutic interventions, simplifying decision-making for clinicians and equipping them with greater insights to deliver faster, more personalized care for their patients—representing another step toward delivering precision health.

The acquisition of BK Medical is GE Healthcare’s second acquisition in 2021 within the field of precision health.  In May 2021, GE Healthcare announced the acquisition of Zionexa, a company headquartered in France that develops and commercializes in-vivo biomarkers for guiding targeted therapies in oncology.

Baxter Completes $10B+ Acquisition of Hillrom

On December 13, Baxter International Inc. (“Baxter”) announced the completion of one of the biggest medtech acquisitions of 2021, acquiring Hillrom (a global medical equipment maker headquartered in Chicago) for a purchase price of ~$10.5 billion.  The deal had originally been announced by Baxter in September 2021.

According to a statement on Baxter’s website, “Baxter’s acquisition of Hillrom has formed one of the world’s leading medical technology companies, centered around a shared vision to transform healthcare.”

Baxter’s product portfolio includes diagnostic, critical care, kidney care, nutrition, and surgical products used in hospitals, physician offices, and patient homes.  According to Baxter, the addition of Hillrom’s product lines, including legacy Welch Allyn products that were acquired by Hillrom in 2015, will help Baxter improve care outcomes and broaden access to care.  Hillrom’s products include the MacroView® Plus Otoscope, the Volara™ Oscillation & Lung Expansion Therapy System, the PST 500 Precision Surgical Table, and the Centrella® Smart+ Bed.

In a press release, Baxter’s chairman Jose E. Almeida stated:

The Baxter-Hillrom combination unlocks the next phase of our transformation, presenting a new wave of potential to drive greater impact for patients, clinicians, employees, shareholders and other communities we serve worldwide.  Integrating our complementary capabilities introduces additional opportunities for growth across our broad geographic footprint and also creates remarkable new possibilities for connectivity with leading-edge digital health innovation focused on enhancing care, lowering costs and increasing workflow efficiency.

According to the press release, Baxter expects the combination to result in ~$250 million of annual pre-tax cost synergies within 3 years.

Two Drugs Recalled Due to Manufacturing Issues

By Mark Rubinshtein

(December 13, 2021) Two pharmaceutical companies have issued recalls in December due to manufacturing issues that may impact the safety and quality of their drug products.

Edge Pharma issued a voluntary recall for all drug products produced in its FDA-registered 503B outsourcing facility in Colchester, VT.  Edge stated that products were removed as a result of “process issues” that may have impacted the sterility of its drug products.  The recall includes a wide variety of sterile products.  These include lidocaine, vancomycin, norepinephrine, and methotrexate, as well as a number of non-sterile products.  The use of non-sterile drug products that are intended to be sterile may result in serious, possibly fatal, infections.

Also this month, Teligent, Inc. issued a voluntary worldwide recall on two lots of their topical lidocaine solution due to superpotency.  The two lots had been distributed throughout the United States.  Superpotent lidocaine can be dangerous to patients and has the potential to cause systemic toxicity leading to hypotension, brachycardia, and possible cardiovascular collapse. In October, the New Jersey company issued a similar recall in connection with five lots of topical lidocaine solution.

Fortunately, no adverse events related to the December recalls by either Edge or Teligent have been reported.

FDA Breakthrough Device Designation for Biology-Guided Radiotherapy (“BgRT”) Device

On December 1, 2021, RefleXion Medical, Inc. (“RefleXion”), announced that the U.S. Food and Drug Administration (“FDA”) has granted the company breakthrough device designation for its biology-guided radiotherapy (“BgRT”) for lung tumors.

The FDA breakthrough devices program:

is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.  The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

Further details regarding the breakthrough devices program can be found here and here.

According to RefleXion, “the breakthrough potential of BgRT lies in its ability to detect and then immediately treat moving tumors.  It is the first and only technology to use injected radiotracers to produce active signals, called emissions, from each tumor to guide treatment delivery” and “aims to remove the uncertainty of guiding radiation delivery using images taken days before treatment.” Many patients with stage four cancer cannot use current forms of radiotherapy because existing technology is unable to efficiently track and treat multiple tumors.  “The unmet need in lung cancer is staggering,” said Todd Powell, president and CEO of RefleXion.  According to Cancer.Org, “[l]ung cancer is the most common cause of cancer-related death,” accounting for 25% of all cancer deaths in the United States.

As RefleXion explains, the use of PET emissions in BgRT to guide treatment makes the “cancer itself act as a fast, biological fiducial continuously signaling its locations even during motion.”  As the PET tracer collects in the tumor, “a series of positron annihilation events occur resulting in the emission of two photons almost 180 degrees to each other.”  The detector in the RefleXion X1 device finds these emissions and outputs images in real time.  A video of RefleXion’s X1 Machine (shown below), used for BgRT, can be seen here.

 

Johnson & Johnson to Separate its Consumer Health Business

Johnson & Johnson announced on November 12, 2021, that it is planning to separate its Consumer Health Business and create a new publicly traded Consumer Health Company. The press release states that the planned separation is expected to provide enhanced operational performance, drive growth, and unlock significant value.  As the press release states:

This planned transaction would create two businesses that are each financially strong and leaders in their respective industries. We believe that the new Johnson & Johnson and the New Consumer Health Company would each be able to more effectively allocate resources to deliver for patients and consumers, drive growth and unlock significant value. Importantly, the new Johnson & Johnson and the New Consumer Health Company would remain mission driven companies with exceptional brands, commitments to innovation, and remarkable talent. Each company would carry on the Johnson & Johnson legacy of putting the needs and well-being of the people we serve first.

According to its press release, the new Consumer Health Company will have a portfolio of brands and companies such as Neutrogena, AVEENO®, Tylenol®, Listerine®, JOHNSON’s®, BAND-AID®, and others.  The new Johnson & Johnson will maintain its pharmaceutical capabilities (including DARZALEX, ERLEADA, IMBRUVICA, STELARA and TREMFYA) and medical device capabilities in interventional solutions, orthopaedics, surgery, and vision.

According to the press release, the new Johnson & Johnson expects to generate revenue of approximately $77 billion USD while the new Consumer Health Company is expected to generate revenue of approximately $15 billion USD in full year 2021. The planned separation is to be completed in 18 to 24 months.

Johnson & Johnson’s press release is available here.

FDA Issues Draft Guidance for Software Contained in Medical Devices

On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” originally released in May 2005.

In a press release Bakul Patel, director of the FDA’s Digital Health center, stated:

 “As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into medical devices. The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions that is aligned with current standards and best practices.”

The draft guidance pertains to software in a medical device (“SiMD”) and software as a medical device (“SaMD”). The Regulatory Affairs Professional Society (RAPS) describes SiMD as “software that is a part of a medical device or controls it” and SaMD as “software that meets the definition of a device but is not part of the overall device’s hardware.” According to the FDA, both SiMD and SaMD are “device software functions.”

The draft guidance is intended to cover: firmware and other means for software-based control of medical devices, stand-alone software applications, software intended to be operated on general-purpose computing platforms, dedicated hardware/software medical devices, and accessories to medical devices when those accessories contain or are composed of the software.

Portions of the draft guidance to consider include the software device documentation and software risk management requirements. Software may require a basic or enhanced level of documentation, depending on risk to a patient, user, other individual, or environment.  A risk assessment and risk management plan may be required.

The draft guidance can be found here.

Federal Circuit Reverses PTAB’s Invalidation of Patent Claims for an Artificial Heart Valve (Snyders vs St. Jude)

On October 5, 2021, the U.S. Federal Circuit reversed a finding of invalidity by the Patent Trial and Appeal Board (PTAB) for patent claims related to an “artificial valve for repairing a damaged heart valve.”  St. Jude Medical LLC (“St. Jude”) filed for an inter partes review (IPR) at the PTAB for U.S. Patent No. 6,821,297, entitled “Artificial Heart Valve, Implantation Instrument and Method Therefor,” owned by Snyders Heart Valve LLC (“Snyders”).

In invalidating the claims, the PTAB interpreted the patent claim limitation of a “frame sized and shaped for insertion between the upstream region and the downstream region.”  The PTAB found that the limitation also covers a frame that fits in place after removal of a damaged heart valve.  The cited prior art allegedly also disclosed a valve insert sized to fit the valve after the damaged native valve was removed.  Therefore, the PTAB found that the prior art anticipated the claims.

The Federal Circuit held that the PTAB erred in determining that the “sized and shaped” limitation “does not require the frame be sized and shaped for insertion into a damaged heart valve,” but “only that the frame is sized and shaped for insertion in a position between the upstream region and the downstream region.”  The Federal Circuit reasoned that the PTAB’s construction was incorrect because “it covers frames sized and shaped for installation with the native valve removed, rather than only with the native valve in place.”  The Federal Circuit cited language in the patent specification allegedly stressing that the disclosed artificial heart valve can be inserted without removing the native valve, an alleged express improvement on the prior art.

The Federal Circuit’s decision is available here.

Bioventus’ Shareholders Approve Acquisition of Misonix

Bioventus recently announced that its shareholders approved its agreement to acquire Misonix.  Bioventus agrees to pay Misonix shareholders either 1.6839 shares of Bioventus class A common stock or $28.00 for each share of Misonix common stock held.  The amount paid to Misonix shareholders results in an approximate valuation of $518 million for Misonix, based on share prices from around the time the acquisition agreement was reached.  With the completion of this acquisition, Misonix will become a wholly-owned subsidiary of Bioventus.

Misonix develops minimally invasive therapeutic ultrasonic medical devices and regenerative tissue products for a variety of orthopedic applications.  For example, Misonix is the developer of the BoneScalpel, an ultrasonic bone cutting tool. Additionally, Misonix is the developer of the Nexus, an ultrasonic surgical aspirator for precision hard and soft tissue removal.

In a press release, Bioventus’ CEO Ken Reali stated:

We are pleased by the outcome of today’s vote and thank our stockholders for supporting the acquisition.  The combination with Misonix creates significant value and provides a deeper global portfolio of pain treatments, restorative therapies and surgical solutions for patients.  We are excited to welcome the Misonix team to Bioventus.

Bioventus plans to accelerate the adoption of Misonix’s BoneScalpel and Nexus products through the footprint of Bioventus in the spine surgical solutions area.  Bioventus also plans to augment its current lower extremity product offerings with Misonix’s products.

This acquisition is one of three acquisitions by Bioventus this year.  Earlier this year, Bioventus acquired Bioness, the developer of neuromodulation and rehabilitation medical devices. Bioventus also has an agreement in place to acquire CertiHeal, the developer of the Agili-C implant.

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