HomeIN THE NEWS

IH Interests: IN THE NEWS

AdvaMed: MedTech Grows During Device Tax Suspension

AdvaMed surveyed member companies in the fall of 2016 to assess the impact of the medical device tax suspension implemented in 2015. Responding companies had employees in all 50 states and represented about 30% of the medical device industry.

Read More
FDA Panel Votes to Approve TransMedics Device

The Organ Care System keeps donor lungs warm and perfused during transport.

Read More

AdvaMed: MedTech Grows During Device Tax Suspension

Among their survey results, AdvaMed reported that the suspended device tax was leading to member companies retaining jobs and investing in infrastructure, R&D and novel technology. Specifically:

  • 73% of respondents increased or avoided reducing employment since the tax was suspended;
  • 33% invested in a new research facility, lab, or research infrastructure;
  • 83% reported increased R&D or avoided reducing R&D funding; and
  • 23% reported increasing investment in start-up companies.

Posted April 06, 2017

FDA Panel Votes to Approve TransMedics Device

On Thursday the FDA’s Gastroenterology & Urology Devices panel voted in favor of approving TransMedics’ Organ Care System for the transportation of donor lungs to waiting transplant recipients. The portable system enables organ perfusion, ventilation and monitoring and is intended to preserve donor lungs in a near physiologic, ventilated,and perfused state for transplantation. As TransMedics says on their website, their device “[simulates] the conditions of the human body and [allows] the organ to function as it normally does” and is an alternative to standard cold transport. The OCS has the potential to increase the amount of time the organs are viable and allow the transplant surgeon to assess organ function outside the body, among other benefits.

The panel voted 11-2 that the OCS Lung system is safe; 8-5 that it’s effective; and 9-4 that its benefits outweigh the risks, according to a report from MassDevice. While the FDA is not required to follow the recommendation of the panel, it usually does.

TransMedics is conducting clinical trials to test the device for the transport of the heart and liver. These trials will be used to support U.S. market approval. The OCS Heart and OCS Lung devices are CE-marked and available in Europe, Australia and Canada.


Posted May 22, 2017
Viz Raises $7.5M for AI to Aid in Stroke Diagnosis

The company is developing imaging-based AI to help improve stroke management.

Read More
Hyalex Orthopaedics Raises $16 Million

The company is developing a synthetic biomaterial for cartilage repair.

Read More

Viz Raises $7.5M for AI to Aid in Stroke Diagnosis

San Francisco-based startup Viz closed a $7.5 million seed round led by DHVC (Danhua Capital) and Innovation Endeavors. They were joined by AME Cloud Ventures in a round that will support development of the company’s artificial intelligence platform, whose first application will be stroke. The system will apply machine learning to medical imaging, potentially identifying algorithms that will enable stroke patients to be quickly and accurately diagnosed and referred for further treatment.

The American Stroke Association reports that someone in the U.S. suffers from a stroke every 40 seconds; further, stroke is a leading cause of long-term disability and the leading preventable cause of disability in the U.S. This high rate of long-term disability may be attributed in part to inaccurate or incomplete diagnoses or other treatment delays. It is worth noting that the major categorizations of stroke as ischemic, hemorrhagic or as a transient ischemic attack (TIA or mini-stroke) all require different interventions and follow-up, so minimizing time to an accurate diagnosis is essential.

Viz CEO Chris Mansi, who trained as a neurosurgeon, describes the potential of his company’s technology as follows: “Viz is like having the best radiologist in the world on your team, a teammate who never gets tired, takes a vacation or stops learning.” In addition to stroke, the company plans to expand its applications to other time-critical emergency medicine indications.

The promise of big data has been evolving for years, and radiology has been one of the first, most visible opportunities. Another San Francisco-based company, Enlitic, is taking a broad approach to patient management, developing what promises to be a rich decision support platform based upon an array of clinical information (including radiology, pathology and laboratory results as well as other data). They raised $10M in a Series A round in 2015, and they debuted the first application of the system, a lung cancer screening tool, last fall. AIDoc, Zebra Medical Vision and Arterys are also among the companies in this active space, which has the potential to provide powerful tools to increase efficiency and accuracy in diagnostics and improve patient care.


Posted May 30, 2017

Hyalex Orthopaedics Raises $16 Million

Last week we learned about a new cartilage repair company, Boston-based Hyalex Orthopaedics, who raised $16 million in a Series A. The round was led by Canaan Partners, who were joined by Osage University Partners and Johnson & Johnson Innovation. Funds will be used to support development of the company’s Hyalex synethetic biomaterial, a polymer licensed from Stanford University that has “properties that mimic the structure and function of the hyaline cartilage” found in articulating joints such as the hip, knee, shoulder and ankle. The press release says that successful development of Hyalex may help the millions of patients suffering from osteoarthritis avoid or delay joint replacement surgery.

Cartilage repair remains a true unmet need, as once the body’s articular cartilage degenerates, it can’t be restored on its own. A number of companies have preceded Hyalex in the quest for a solution, including Histogenics, which embeds autologous cartilage cells in a collagen scaffold intended to be placed in the knee, and BioSyntech, which developed the BST-CarGel scaffold for the knee that was sold first to Piramal and more recently to Smith & Nephew. Neither of these products have been approved for sale in the U.S. market. In December 2016, Vericel received FDA approval for the MACI, which loads autologous cultured chondrocytes on a porcine collagen membrane; this was the first U.S. approval for a product of this type. Vericel also markets Carticel, an FDA-approved biologic where autologous chondrocytes are cultured and then implanted into the patient’s knee cartilage defect. This technology is said to create a hyaline-like cartilage repair tissue.

Hyalex says what makes their product unique is that the material “offers the ability to maintain an extremely low wear profile even at high loads,” making the material suitable for use in highly weight-bearing joints, like the hip and knee. Lampros Kourtis, Ph.D., Hyalex’s co-founder and chief technology officer, adds, “Our vision is to leverage Hyalex’s unique mechanical, friction and wear properties to replace arthritic cartilage while sparing healthy bone.”

In conjunction with their financing, Hyalex also announced the appointment of several key leadership roles at the company. Mira Sahney was appointed president and CEO, joining Hyalex from her role as senior vice president and general manager at Smith & Nephew. Wende Hutton, general partner for Canaan Partners, Bill Harrington, managing partner of Osage University Partners and Renee Ryan, vice president, venture investments at Johnson & Johnson Innovation will join Hyalex’s board of directors.


Posted June 06, 2017
Medtronic Launches MiniMed 670G for Type 1 Diabetes

The hybrid, closed-loop device moves closer to an artificial pancreas.

Read More
Myomo Goes Public

Powered orthotics company Myomo raises $7.9 million.

Read More

Medtronic Launches MiniMed 670G for Type 1 Diabetes

Medtronic announced last week that they’ve launched their MiniMed 670G for type 1 diabetes, which combines an insulin pump with continuous glucose monitoring technology to deliver or withhold insulin based on its measurement of the patient’s blood glucose. Blood glucose is checked every five minutes, and the round-the-clock monitoring and automatic administration of insulin represent a significant improvement over the inherent variability in glucose self-monitoring and administration of insulin injections. Further, the device tracks insulin use to identify a personalized range for each patient, with one of the key outcomes measures in the company’s 670G pivotal trial being the device’s ability to maximize time spent in that range.

In a study published in JAMA last September, the investigators reported that users of the MiniMed 670G “experienced less glycemic variability, more time in the target range, less exposure to hypoglycemia and hyperglycemia and reduced A1c” compared to baseline data using sensor augmented pumps. The study enrolled 124 patients, and the company described it as the “largest and longest at-home closed loop study” performed to date. In additional comments on the study, Medtronic noted that the 24-hour monitoring and glucose administration reduced some of the challenges of diabetes on patients, particularly at night, when glucose levels are more difficult to monitor and control. It does have some technical limitations – the user has to enter carbohydrates consumed at mealtimes and exercise information – but the technology represents a significant step toward less burdensome diabetes management.

This advance comes at a cost. Price estimates on the device range from around $6,000 to $9,000, though the cost to the patient will vary based on insurance coverage. Medtronic, which initially received approval for the device “earlier than expected” (only 104 days after their PMA filing), has spent the months since the approval in late 2016 working to promote payer coverage and perform customer education, among other activities. While it remains to be seen whether the cost and coverage will be an impediment to adoption, the careful rollout does seem to be delivering some early returns on the promise of the system. The company says that a training phase was initiated in March to precede a broader launch, and that program returned “excellent feedback on system performance, clinical outcomes and user experience … including a 94 percent overall satisfaction rate with the training and onboarding.”


Posted June 13, 2017

Myomo Goes Public

Cambridge-based Myomo, a commercial-stage developer of a myoelectric arm orthosis whose technology is exclusively licensed from MIT, went public on the NYSE MKT last week (NYSEMKT: MYO) and is the first company to trade on the listing under SEC Regulation A+. The regulation is designed to facilitate access to the public markets for early-stage growth companies, as Regulation A+ allows any investor to participate in a public offering, not just accredited investors. Companies are allowed to raise up to $50 million in a public offering under Regulation A+.

Myomo markets the MyoPro myoelectric arm orthosis. The device is described as a lightweight, wearable powered brace that can help restore arm or hand function in individuals who have suffered a stroke, spinal cord or nerve injury or experience another neuromuscular disability. The device uses the wearer’s own muscle signals to control arm and hand movements and can broaden therapy options for patients with weakened or paretic upper limbs.

Last week, the company announced that they raised $5.0 million from the sale of shares of its common stock, at a price to the public of $7.50 per share. Simultaneously, they closed on a a private sale of of restricted securities to accredited investors (mostly early investors in Myomo, according to the press release) that netted $2.9 million. The combined capital raised of $7.9 million will be used to “continue to invest in the MyoPro product line,” as well as support sales and marketing efforts both domestically and internationally.


Posted June 19, 2017
Dune Medical Raises $12.3M

The company will expand MarginProbe beyond breast cancer.

Read More
House Re-Authorizes Medical Device User Fees

The bill will re-authorize user fees, which support the FDA's review budget, through 2022.

Read More

Dune Medical Raises $12.3M

Dune Medical Devices announced the closing of a $12.3 million financing round led by Canepa Healthcare, ATON Partners and the Kraft Group. The company has received $66.5 million in funding to date, with the most recent round planned to support product expansion beyond the company’s initial breast cancer indication.

The MarginProbe System, the company’s first product, utilizes radiofrequency spectroscopy technology to detect microscopic residual cancer in real time during a surgical procedure. As clean margins are critical in preventing disease recurrence, the device enables the surgeon to remove additional tissue during the primary procedure while the patient is still under anesthesia, greatly reducing the costs and potential complications associated with multiple surgeries. The device was first developed for use in breast lumpectomy procedures, where the company estimates 20-30% of women need additional surgical procedures to remove residual cancerous tissue. Across three large pivotal randomized control trials and several other peer reviewed studies, Dune Medical reports that 2,500 women were found to have a 79% reduction in re-excision procedures when the MarginProbe System was implemented.

With this latest funding announcement, the company is now planning on expanding the use of the MarginProbe to prostate, colon, lung and pancreatic cancers. Further, in August 2016, Dune Medical received the European Union Horizon 2020 Research Grant to develop their biopsy system, which the company says will allow radiologists and surgeons to immediately characterize tissue abnormalities along the tip of a biopsy needle.


Posted July 13, 2017

House Re-Authorizes Medical Device User Fees

Last week the House voted to pass the FDA user fee re-authorization act, which allows for the collection of fees from drug and device manufacturers to support the FDA in its review activities. This latest iteration of the legislation would update the target base user fees collected from devicemakers to $130.2 million in FY2017, $183.3 million in FY2018 and reaching $213.7 million in FY2022.

An infographic produced by AdvaMed, the medical device lobby which is supportive of the re-authorization act, summarized some of the commitments the FDA is offering under the renewed agreement. They include shortening review times for 510(k) applications and PMAs, incorporating novel study designs and attributes, such as the use of real-world data and patient-focused endpoints, into submissions and providing more specifics in deficiency letters, so that companies may better understand the issue and how to remedy it.

Now that the bill has passed the House, the next step is the Senate to vote on their version of the bill. Congress has until September 30 to finalize the legislation, at which point the prior user fee agreement expires.


Posted July 17, 2017
MiMedx Divests Stability Biologics

MiMedx will divest the bone graft subsidiary to focus on its biopharma strategy.

Read More
Book Review: Immunity by William E. Paul, MD

We like and recommend this primer on one of the hottest topics in the life science field.

Read More

MiMedx Divests Stability Biologics

MiMedx announced last week that they would divest their subsidiary Stability Biologics LLC to the stockholders from whom MiMedx acquired the company in January 2016. This move will enable the company to focus on their biopharma strategy, which is based on further developing their human placental tissue platform technology.

Stability developed and processed bioactive bone graft products and tissue allografts, including structural/particulate bone, structural allografts, demineralized bone matrix (DBM), skin products for burns and traumatic wound care and the bone grafting material Physio. As MiMedx developed its plan to transition fully to a biopharma company, which it intends to complete by 2020, they concluded that Stability was no longer a strategic fit.

MiMedx is now focusing on completing BLA submissions for AmnioFix Injectible, their lead product candidate, for the treatment of muscloskeletal pain. The company recently announced that it has submitted INDs for phase III plantar fasciitis and achilles tendonitis clinical trials, with the BLAs expected to be submitted in 2019 and launches projected for mid-2020. The company is also performing clinical investigations into the use of the treatment for osteoarthritic knee pain, with a BLA in that indication expected to be filed in 4Q:20. And while the company is primarily focused on the wound healing and orthopedic therapeutic areas, they have publicly announced potential applications in other sectors as well, including pain management, respiratory and cardiac.


Posted August 29, 2017

Book Review: Immunity by William E. Paul, MD

One of the hottest topics in the life science field is the immune system.  Treatment modalities from vaccines to antibiotics to cancer immunotherapy have been developed from centuries of study of this complex subject.

We found the book Immunity by the late William E. Paul, MD to be a useful primer for general readers looking to familiarize themselves with the immune system.  Practitioners seeking to brush up on immunity’s latest research developments will also find Immunity worthwhile.

Dr. Paul, who was the chief of the Laboratory of Immunology at the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, is an authority on the topic.  By presenting the three laws of the human immune system – universality, tolerance, and appropriateness – he provides a comprehensive blend of science, history, and autobiography.

Perhaps most interesting to us were Paul’s useful futuristic suppositions about new immunological technologies and research frontiers.  These include the use harnessing the immune system for cancer therapy, epigenetics, genetic engineering and the like.

Much of this work relates to medical devices in areas such as designing miniature implantables that are be ignored by the immune system (e.g. less scarring), developments in diagnostic tools such as immunodiagnostics, real-time immune system imaging that helps in efficient disease management and so forth.

We like and recommend this book.


Posted September 05, 2017
NuVasive Launches LessRay

LessRay is a software platform that aims to reduce OR radiation exposure.

Read More
Optinose Receives FDA Approval & Plans IPO

EXHANCE is a novel inhaler used for the treatment of nasal polyps.

Read More

NuVasive Launches LessRay

NuVasive announced last week the market launch of their LessRay product, a software platform that enhances low-dose images acquired intraoperatively to full-dose quality. This allows for less radiation exposure in the OR, which is critical for spine and orthopedic surgeons, who may receive a lifetime occupational exposure to radiation with the first decade of their careers. LessRay, which was acquired from SafeRay Spine in September 2016, also marks the entry of NuVasive into capital equipment sales.


Posted September 19, 2017

Optinose Receives FDA Approval & Plans IPO

Optinose received FDA approval for their EXHANCE device for the treatment of nasal polyps and their symptoms, a condition that may affect up to 10 million adults. The product utilizes the company’s novel Exhalation Delivery System (EDS) to deliver a steroid (fluticasone propionate) deep into the nose. The unique design requires the patient to actuate the pump spray into one nostril while simultaneously blowing into the mouthpiece of the device.

The development program for XHANCE included five clinical trials evaluating over 1,500 adult patients, including two randomized, double-blinded, placebo-controlled Phase 3 pivotal trials in adults with nasal polyps (NAVIGATE 1 and NAVIGATE 2) and two open-label Phase 3 clinical trials in adults with chronic sinusitis with and without nasal polyps (XHANCE-12 and XHANCE-3). In their last release of data from NAVIGATE II, the company delivered positive results including reduction in the co-primary endpoints of nasal congestion/obstruction and endoscopically measured total polyp grade. Further, XHANCE-12 showed improvement in patient-reported symptoms.

On the heels of FDA approval comes the announcement that Optinose plans to join fellow ENT and sinusitis companies Intersect ENT and Entellus on the public markets. Optinose seeks to raise $100 million in an IPO, which the company will use to fund the launch of XHANCE in 2Q:2018, to run a pediatric study on the use of the device and for general working purposes.


Posted September 26, 2017
CartiHeal Treats First Patients on Agili-C IDE Study

The company is developing a knee implant for cartilage defects.

Read More
FDA Clears TransEnterix's Robotic Surgery System

The Senhance is the first new abdominal surgical robotic system cleared since 2000.

Read More

CartiHeal Treats First Patients on Agili-C IDE Study

Israel-based CartiHeal announced last week that they have opened a multi-center IDE study that will evaluate the use of their Agili-C implant against microfracture and debridement for the treatment of cartilage or osteochondral defects. Seventeen subjects have been enrolled and treated at three EU centers so far, and the company is in the process of opening additional sites in the EU, U.S. and Israel. The study will enroll a minimum of 250 subjects overall and be used to support a U.S. PMA application. The device is CE marked in Europe.

Agili-C is described as a cell-free, off-the-shelf implant that aims to regenerate damaged hyaline cartilage, thus preventing progression to osteoarthritis. The implant is biphasic, consisting of modified aragonite and hyaluronic acid in the cartilage phase and calcium carbonate in the bone phase, and is implanted in a press-fit, single-stage procedure.


Posted October 09, 2017

FDA Clears TransEnterix's Robotic Surgery System

TransEnterix announced last week that the FDA cleared their Senhance surgical robotics system for use in gynecologic and colorectal laparoscopic surgical procedures. The device has already received the CE mark.

Building on the known benefits of robotic surgery to reduce pain, scarring and recovery time after surgery, the Senhance’s differentiating features include haptic feedback and eye-sensing camera control. The Senhance also utilizes an open architecture, which allows hospitals to integrate the system into existing operating room equipment. TransEnterix also emphasizes the economic benefits of their system, which will compete with Intuitive’s da Vinci, by noting that the Senhance is operated with fully reusable instruments.

Also in development at TransEnterix is the SurgiBot System, a single-port robotic surgical platform. That system is not yet available in any market.


Posted October 18, 2017
Regentis Enrolls First Patients in IDE Cartilage Trial

The study will compare GelrinC to microfracture.

Read More
Device Company CEOs on Innovation and M&A

Our new video series focuses on medical device technology and trends.

Read More

Regentis Enrolls First Patients in IDE Cartilage Trial

Regentis announced that the first three cases have been performed in their IDE study for GelrinC, a novel hydrogel that is applied after standard microfracture for the treatment of focal knee cartilage defects. The liquid formulation becomes solid after exposure to UV light, conforming to the size and shape of the lesion. The company says the implant acts as a scaffold for the growth of new cartilage and that it completely degrades within 6-12 months.

The first three patients were treated at two U.S. sites (Peninsula Orthopaedic Clinic in Salisbury, Maryland and Mansfield Orthopaedics at Copley Hospital in Morrisville, Vermont) and one Danish site (Aarhus University Hospital in Aarhus). The study’s ClinicalTrials.gov page reports that 181 subjects will be enrolled overall. Safety and efficacy endpoints for patients who receive the GelrinC treatment will be compared to a historical microfracture control arm. The company says this study design will enable faster enrollment and thus faster approval.

GelrinC has CE mark approval and is sold in Europe; in the U.S., the ongoing clinical trial will support a PMA in the U.S.


Posted December 01, 2017

Device Company CEOs on Innovation and M&A

We’re excited to launch the InnovaHealth Partners video series with interviews from thought-leading medical device CEOs on innovation, improving patient outcomes, meeting hospital expectations for value and what strategic acquirers are looking for in the companies they target. What’s most important in medical device innovation? How do medical device companies differentiate from their peers? How do innovative companies address the cost constraints of hospitals? We sat down with Stavros Vizirgianakis, President and CEO of Misonix, Paul Nichols, President and CEO of Bio2 Technologies and Philip Sawyer, President and CEO of Invuity to learn more.


 

Many thanks to Stavros G. Vizirgianakis, Paul Nichols and Philip Sawyer for their time and insight.


Posted December 04, 2017