Medtech Highlights: Q2 2018
Medtronic aims for 4% growth and announces an FDA approval
Medical device company, Medtronic is targeting a 4% annual increase in revenue through investments in higher-growth technology markets, according its plans outlined at its biennial investor briefing in New York in June.
In order to increase savings in its global operations, the company plans to continue consolidating its manufacturing footprint from a peak of 92 to closer to 55 inover the next few years. The company also plans to reduce its supply chain base by about 50%.
At present, Medtronic maintains about 70 sites but will lean towards contract manufacturing where possible.
The intended financial aims are to grow adjusted earnings per share by 8%, expand its underlying operating margin by 40 to 50 basis points, return at least half of its free cash flow to shareholders and continued growth in emerging markets.
Separately in the month, the Irish headquatered company announced that the U.S. FDA has approved its state-of-the art Deep Brain Stimulation (DBS) Clinician Programmer and ActivaProgramming Application. The ActivaProgramming Application was designed with the input of over a hundred clinicians globally and is managed on the Samsung Galaxy Tab S2 tablet interface to enhance the clinical programming experience, streamline workflows and provide actionable information to support neurologists and neurosurgeons in their treatment of patients with neurological diseases such as Parkinson’s and Dystonia.
Headspace targets 2020 FDA approval for meditation app
Headspace is aiming for FDA capproval for a prescription based meditation app by 2020.
The mindfulness and meditation specialists have formed a digital health subsidiary to test the app in randomised controlled trials, clinical validation and regulatory processing.
Founded in the U.K. in 2010, Headspace is a key player in consumer-focused, digitally delivered, guided meditation.
With efficacy being its key hurdle on the path to FDA approval, Headspace is gathering efficacy data through studies and analysis which is says are are rigorous, multi-site and high-calibre.
Amazon eyes health-tech
Amazon is understood to have created a research division with a view to extending its reach into healthcare technology, cancer research and medical records.
According CNBC reports, the company’s Grand Challenge research group has been working with Fred Hutchinson Cancer Research Center to develop machine learning tools for oncology.
A Fred Hutch spokesperson told CNBC that it has several early-stage projects underway with tech pioneers, including Amazon, Microsoft and Tableau Software, and that hopes to preview them later in the year.
According to CNBC, Grand Challenge sits within the Amazon Web Services divison and team members are chosen through its annual “Think Big” competition, involving presentations of the next big ideas.
Amazon has already explored into the pharmacy and drug distribution spaces. Some industry analysts believe the company could dive in as early as next year.
Earlier this year, Amazon hired FDA’s former chief informatics officer, Taha Kass-Hout, M.D., who was the agency’s inaugural CIO who led the FDA’s DNA sequencing data programme – PrecisionFDA.
Medtech Highlights: Q1 2018
NeuroVision looks to snare $15M in series C financing round
Diagnostics player NeuroVision is looking to capture $15 million in a series C round of financing with an initial close of $11.2 million.
Funds from the financing will be used to support validation and gain regulatory approval for its retinal imaging technology designed for the early detection of Alzheimer’s disease.
The financing round is being led by Wildcat Management with participation from Johnson & Johnson Innovation, Nikon-SBI Innovation Fund, Whittier Ventures and VSP Global.
NeuroVision’s test identifies build-up of amyloid-beta protein in the retina, which has similar characteristics to the brain. Studies have shown that amyloid-beta plaques that build up in Alzheimer’s patients’ brains also accumulate in the retina. The hope is that monitoring the retina could help doctors spot Alzheimer’s earlier and guide treatment.
Datavant Acquires Universal Patient Key and Closes $40M Financing Round
Datavant has acquired Universal Patient Key (UPK), a leading provider of HIPAA-compliant de-identification services for healthcare data.
UPK has created a suite of software products that de-identify structured and unstructured health data through HIPAA-compliant methodologies.
By using UPK’s industry-leading software and services, healthcare stakeholders can securely share patient-level healthcare data while minimizing the risk of unauthorized access and patient re-identification. The services enable the shared use of longitudinal, real-world evidence to further medical research, improve health outcomes, and reduce the cost of delivering care, while at the same time protecting the anonymity of individual patients.
Check-Cap Receives CE Mark Approval for C-Scan®
Check-Cap Ltd., a clinical-stage medical diagnostics company engaged in the development of C-Scan®, an ingestible capsule for preparation-free, colorectal cancer screening, announced it has received CE Mark approval for the C-Scan system.
The C-Scan system offers an alternative to current colon cancer screening methods that require laxative preparation and invasive endoscopic procedures. This novel platform consists of a fully autonomous system that utilizes an ingestible, ultra-low dose X-ray capsule combined with a state of the art wireless tracking system, enabling generation of structural information on the lumen of the colon.
This information is used to create 2D and 3D maps of the colon, allowing physicians to identify pre-cancerous polyps and other abnormalities.
C-Scan is designed to improve the patient experience and increase the number of adults screened by eliminating procedural requirements frequently cited as barriers to adherence to screening guidelines such as bowel preparation, fasting, and sedation.
Tandem Diabetes Care Announces Closing of $69 Million Underwritten Public Offering of Common Stock
Tandem Diabetes Care, a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, has announced the closing of its previously announced underwritten public offering of 30 million shares of common stock at a price to the public of $2.00 per share.
In addition, the underwriters fully exercised an option to purchase 4.5 million additional shares of common stock at the public offering price. All of the shares in the offering were offered by Tandem, with gross proceeds to Tandem of $69 million from the offering of an aggregate of 34.5 million shares.
HeartFlow Completes Series E Financing, Securing $240 Million
HeartFlow, Inc. has announced the closing of its Series E financing, securing $240 million. The company will use the proceeds from this financing to ramp up commercial expansion of the HeartFlow® FFRct Analysis, continued technology innovation and additional clinical studies.
The HeartFlow Analysis is a non-invasive technology that creates a personalized 3D model of the heart to help clinicians diagnose and treat patients with suspected heart disease.
The financing includes investments from Wellington Management, Baillie Gifford & Company and existing investors.
Q4 2017 Highlights
TransEnterix announces first U.S.purchase agreement for Senhance™ Surgical System
TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery has announced that Florida Hospital has entered into an agreement to purchase the Company’s Senhance™ Surgical Robotic System.
The Florida Hospital Orlando campus will be home to the first commercial unit of the Senhance Surgical System to be installed in the United States.
The recently FDA-cleared Senhance Surgical System represents an innovative technology designed to assist surgeons in performing minimally invasive surgery. The system features multiple robotic arms that are controlled by a surgeon seated comfortably at a console. The surgeon controls small surgical instruments with robotic precision while at the same time moving a small scope that tracks the eye movement of the surgeon.
The Senhance is the first surgical robotic system to offer the security of haptic force feedback that allows surgeons to feel the forces the instruments generate when handling delicate tissue. The Senhance represents a new era of digital laparoscopy designed to support responsible economics for the hospital, patient and today’s value-based healthcare system.
Medtronic acquires gastro diagnostics Crospon in $45m deal
Medtronic has acquired gastrointestinal disorder diagnostic company Crospon. Medtronic has not confirmed the exact value of the deal but London’s Times newspaper has reported it could be worth up to $45 million (EU €38 million).
West of Ireland based Crospon, produces endoscopic diagnostics, including its FDA approved Endoflip system, which includes the company’s Flip topography module designed to allow for the assessment of patient motility disorders during endoscopy.
The system includes imaging software that displays esophageal contractility patterns in real time on a touchscreen display and allows for the investigation of conditions including achalasia, GEJ outflow obstruction and other major or minor peristalsis disorders during endoscopy.
FDA approves First Medical Device Accessory for Apple Watch
AliveCor has announced FDA clearance of KardiaBand in the U.S., allowing Apple Watch users to discreetly capture their EKG anytime, anywhere in order to quickly detect normal sinus heart rhythms and atrial fibrillation (AFib), the most common heart arrhythmia.
KardiaBand is the first FDA-cleared medical device accessory for Apple Watch. It can record an EKG in 30 seconds with just a touch of its integrated sensor. Results from the Kardia App are displayed on the face of Apple Watch.
KardiaBand retails for $199 plus an annual subscription fee of $99 a year.
Hancock Jaffe Laboratories sets terms for $13 million IPO
Hancock Jaffe Laboratories, which is developing bioprosthetic devices for cardiovascular surgeries, announced terms for its IPO. The Irvine based company plans to raise $13 million by offering 1.88 million shares at a price range of $6 to $8. At the midpoint of the proposed range, Hancock Jaffe Laboratories would have a market value of $62 million.
It plans to list on the Nasdaq. WallachBeth Capital and Network 1 Financial Securities are working joint on the deal. IPO timing has not been disclosed.
Virtual Incision Announces $18 Million Series B Funding for Miniaturized Surgical Robots
Virtual Incision Corporation has has raised $18 million in Series B funding.
The round was co-led by new investor Sinopharm Capital, the private equity fund initiated by Sinopharm Group, China’s largest healthcare company, and existing investor Bluestem Capital, with participation from PrairieGold Venture Partners and others.
This financing will support the company’s premarket notification submission to the U.S. FDA for its next-generation miniaturized robotically assisted surgical device (RASD). The Virtual Incision RASD is designed to enable physicians to perform less-invasive general surgery abdominal procedures that today are usually performed via large, open incisions, including multi-quadrant surgeries such as colon resection.
While similar to other RASDs with regard to intended use, Virtual Incision’s technology takes a new and unique approach to robotically assisted surgery by using a small, dexterous and self-contained surgical robot that does not require a dedicated operating room or specialized infrastructure.
The company’s key focus is on the under-served 80% of the market where smaller and simpler solutions are in demand.
Genesis Innovation Group launches $10m Cultivate (MD) medtech venture fund
Mhicigan based Genesis Innovation Group has created a Cultivate(MD) Capital Fund, which aims to manage $10 million to invest in early stage healthcare companies with a focus on medical device and orthopedic technologies.
The company says it expects the fund to be fully operational and seeking companies to invest in by early 2018. The fund will focus on investing in early stage medtech companies with “demonstrated evidence of effectiveness” with goals of reducting the cost of healthcare while improving outcomes for patients