Insulet taps former Medtronic finance exec McMillan as CFO | Personnel Moves – January 8, 2019

Insulet CFO Wayde McMillan

Insulet (NSDQ:PODD) said yesterday that it tapped former Medtronic minimally invasive therapies CFO and finance VP Wayde McMillan as its new chief financial officer, replacing Michael Levitz.

The Acton, Mass.-based diabetes-focused medtech company said that McMillan will join the company in February and that Levitz will continue as an advisor for a period following the succession to ensure a smooth transition. McMillan will officially take the role of CFO on March 1.

Prior to joining Insulet, McMillan held executive roles in finance at Medtronic, having come to the company during its acquisition of Covidien in 2015. After the acquisition, McMillan helped reorganize the new acquisition into the Medtronic Group structure, the company said.

“We are excited to welcome a leader of Wayde’s caliber to Insulet as the company transitions to profitability, expands internationally, and enters its next phase of rapid growth. Wayde has significant expertise scaling large organizations and a thorough understanding of the strategies we are pursuing globally to accelerate growth and build on our strong foundation. We look forward to benefitting from Wayde’s experience as we continue to position the company for long-term success and solidify our leadership in the global management of diabetes. On behalf of the board of directors and the entire company, I want to thank Mike Levitz for his numerous contributions, as well as his support during this transition period. Over the last four years, Mike has helped develop and execute our strategic imperatives, strengthen our infrastructure and capabilities in support of future growth, and generate exceptional value for shareholders. We wish Mike all the best in his future endeavors,” prez & CEO Shacey Petrovic said in a prepared statement.

“I am honored to join the team at Insulet, a company with a strong mission dedicated to improving the lives of people impacted by diabetes. I look forward to working alongside the Insulet leadership team and contributing to the company’s initiatives to drive growth, profitability and value creation for shareholders,” McMillan said in a press release.

 Senseonics appoints Isaacson as CFO

Senseonics (NYSE:SENS) said yesterday that it named Jon Isaacson as its new chief financial officer, replacing R. Don Elsey.

Elsey will remain on with the Germanton, Md.-based company in an advisory role to support the transition and to assist in preparation of the company’s annual report filings for the previous fiscal year. Elsey is slated to stay on until his planned retirement date of February 28, or a later date if another agreement is made.

Prior to joining Senseonics, Isaacson acted as CFO of Edelman Financial Services from November 2017 to December 2018, and as managing director of private equity firm American Capital, the company said.

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 Livongo names Shapiro as CFO

Livongo said last week that it appointed board member and audit committee chair Lee Shapiro as its new chief financial officer, effective on February 1.

Shapiro currently serves as a member of the board and audit committee for Medidata Solutions and as the audit committee chair of Tivity Health, Mountain View, Calif.-based Livongo said. He also served at Allscripts Healthcare Solutions as president from 2001 to 2012, the company added.

“I couldn’t be more excited about working with Lee. His intimate knowledge of Livongo, his close working relationships with the leadership team, and his connections across the industry, including virtually every analyst in the healthcare and technology space, will allow us to rapidly accelerate our business and better serve our members and clients,” CEO Zane Burke said in a press release.

“Lee’s experience in scaling companies is a perfect fit for Livongo as the company moves to the next level. I speak for the entire team in sharing my enthusiasm in gaining Lee’s experience in building great companies for Livongo,” exec chair Glen Tullman said in prepared remarks.

“I have been impressed with what the Livongo team has accomplished in such a short time. As the company continues its rapid acceleration, my hope is to contribute in both financial and strategic ways to serve Livongo’s mission of empowering more people with chronic conditions to live better and healthier lives,” Shapiro said in a prepared statement.

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 Reva Medical lifts Elkolli to CFO

Reva Medical (ASX:RVA) said last week that it promoted Leigh Elkolli to the office of chief financial officer and corporate secretary, replacing Brandi Roberts who resigned, effective January 4.

Elkolli joined San Diego-based Reva Medical in August 2017 as finance senior director and corporate controller, the company said. Elkolli previously worked with privately held biotech company Avidity Biosciences, serving as finance director.

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 Wright Medical shuffles the exec roster

Wright Medical (NSDQ:WMGI) yesterday announced a number of internal organizational changes, including lifting current prez Kevin Cordell to the position of chief global commercial officer and exec VP and promoting senior VP and CFO Lance Berry to the newly created position of chief financial and operations officer and exec VP.

Cordell joined Wright in 2014, and has helped integrate the U.S. commercial teams of Tornier after the companies merged, Wright said. In conjunction with his promotion, current int’l prez Peter Cooke will assume the role of president of emerging markets, Australia and Japan and current upper extremities marketing VP Steve Wallace was promoted to int’l prez, the company said.

In his new role, Amsterdam-based Wright Medical said that Berry will be responsible for global finance and accounting, operations, quality, regulatory, information technology, strategy and corporate development.

“Wright Medical is quickly becoming a $1 billion high-growth medtech company that is built to win in the fast-growing Extremities and Biologics markets.  As we continue to grow and progress, there is a need to better align our team to support long-term revenue growth, profitability and day-to-day execution.  At the same time, we must stay strategically focused to maintain our technology differentiation and leadership positions.  It is with these goals in mind that I am creating two new executive vice president positions, reporting to me, to advance our global commercial focus and to further transform our global business processes. With significant opportunities ahead, these organizational changes will allow for further alignment of our cross functional organizations with a stronger and sharper focus on long-term growth and profitability, including a greater emphasis on the emerging market opportunity.  I am looking forward to working with Kevin and Lance in their new leadership roles and am confident that these appointments, along with our other organizational changes, will further bolster our ability to capitalize on the growth opportunities in front of us and accelerate our market performance,” prez & CEO Robert Palmisano said in a prepared statement.

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BoneSupport expands sales team

BoneSupport today announced plans to expand its sales force, adding an additional 13 sales representatives in “key markets” this year.

The Swedish company said that the objective of the expansion is to increase the market penetration of its antibiotic-eluting Cerament G and Cerament V products.

BoneSupport touted that in April, three studies of its Cerament platform were presented at the British Limb Reconstruction Society meeting, some of which showed improved bone healing and reduced risk of recurrent infections with the use of the Cerament G product.

“Cerament G and V have strong sales momentum in Europe due to their increased use in a wide range of orthopedic indications. The adoption level is particularly high in osteomyelitis, a challenging indication that generally requires repeated surgical interventions. We see significant commercial potential for Cerament G and V in multiple important treatment areas, including the much larger trauma indication. Today’s decision to almost double the number of sales specialists in Europe, reflects the sizeable opportunity we see for our Cerament products across the region in indications where we have so far had a relatively low level of penetration,” CEO Emil Billbäck said in a press release.

Earlier this month, BoneSupport said it inked a strategic agreement with Collagen Matrix to expand its product offering to the U.S.

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7 medtech stories we missed this week: May 25, 2018

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From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Mauna Kea wins FDA nod for neurosurgery indication

Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance for its Celivizio 100 series F400 and F800 with new Confocal Miniprobe, the CranioFlex. The clearance allows the device to be used during neurosurgical procedures. The Cellvizio 100 with CranioFlex gives allows for imaging of tissue internal microstructures and allows for identification of cells and vessels and their organization in the central nervous system during cranial diagnostic and therapeutic procedures. The F400 series operates at 488 nm and the F800 model operates at 800 nm.

2. Bonesupport, Collagen Matrix ink deal

Bonesupport has signed a strategic agreement with Collagen Matrix to expand its product offering to the U.S., according to a May 24 press release. The agreement states that Bonesupport will start selling and marketing some of the Collagen Matrix bone graft substitute products under its own brand and through its own distribution network in the fourth quarter of this year.

3. Implanet launches Jazz Evo spine implant

Implanet announced in a May 23 press release that it has launched its Jazz Evo implant that is designed to respond to the constraints of vertebral fusion indications in adults. The implant is designed to facilitate the treatment of degenerative pathologies in adults and is part of the company’s Jazz range of products that block the braid with a single screw to ensure optimum clamping on the rod without damaging the braid.

4. MC10 wins FDA nod for BioStamp nPoint wireless patient monitor

MC10 recently received FDA 510(k) clearance for its BioStamp nPoint System, according to a May 16 press release. The system is a wireless, biometric data collection platform that is designed to be used by healthcare professionals and researchers for collecting physiological data continuously in the home or in traditional healthcare settings. It is specifically designed for clinical trials or research studies where continuous collective data is needed. It features flexible, body-conforming rechargeable sensor patches that are reusable and can record data for up to 24 hours. It can be configured to measure, record and display general activity, postural classifications, vital signs and sleep metric with clinical validated accuracy.

5. FDA clears second XableCath peripheral catheter

XableCath announced in a May 24 press release that it has received FDA clearance for its XableCath abrasion tip support catheter. This clearance marks the second clearance for the company after its blunt tip catheter was cleared at the end of 2017. Both XableCath’s designs are designed to easily slide past occluding atheroma through the true lumen of the vessel.

6. CrossRoads Extremity Systems launches DynaForce foot implant

CrossRoads Extremity Systems has launched its Active Stabilization MPJ Implant System, according to a May 22 press release. The company launched the product after it received FDA clearance for its DynaForce system. The DynaForce Active Stabilization MPJ Implant System combines stability and an anatomic plate with active compression of a nitinol clip that is delivered to the operating room in a sterile package.

7. FDA clears Medacta pedicle screw guide

Medacta announced in a May 23 press release that it has received FDA clearance for its MySpine Midline Cortical Pedicle Screw Placement Guide. The MySpine MC system allows surgeons to optimize procedures for both outpatient and inpatient settings for a more rapid patient recovery through accurate and reliable muscle-sparing approaches to posterior lumbar surgery. The system guides the screw to a trajectory in the pedicle that has evolved from a cortical bone trajectory. The system also avoids interference with cranial facet joins and can accommodate larger screw diameters and lengths with four points of cortical bone purchase.

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7 medtech stories we missed this week: March 24, 2017

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From companies receiving CE marking to other companies adjusting their distribution deals, here are 7 medtech stories we missed this week but thought were still worth mentioning.

1. Viveve Medical closes public offering

Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 news release. The public offering price was $4 per share, and the company estimates that the net proceeds from the offering will be nearly $31.7 million after deducting underwriting discounts and commissions.

2. Masimo receives CE Mark for Rad-97 Pulse CO-Oximeter

Masimo announced that it received CE Marking for its noninvasive blood pressure measurements from its Rad-97 Pulse CO-Oxumeter and connectivity hub, according to a March 20 news release. Rad-97 allows clinicians to measure arterial blood pressure in adults, pediatric and neonatal patients. It measures using 3 measurement modes: spot-check, automatic interval and stat interval. The built-in port lets clinicians connect a blood pressure cuff inflation hose right on the Rad-97. It also enables easy and automatic charting of blood pressure data directly from the same monitoring device that measures oxygen saturation, total hemoglobin and other noninvasive parameters. The device has WiFi and Bluetooth connectivity that allows the device to connect to other devices that are nearby. With its user-friendly multi-touch navigation, clinicians can customize the high-resolution, 1080p HD color display to what they need.

3. Glaukos announces reimbursement win

The opthalmic medical technology company Glaukos Corp. has announced that the Current Procedural Terminology (CPT) Editorial Panel of the American Medical Association has given it a 5-year extension to 3 Category III CPT codes that describe insertion of aqueous drainage devices into the anterior chamber of the eye during micro-invasive glaucoma surgery, according to a March 16 news release. Physicians and other healthcare providers use CPT codes to report and receive Medicare reimbursement for services. The 3 CPT codes that received an extension are 0191T, 0253T and 0376T, all of which deal with the iStent device.

4. DiamiR wins $2.75 million grant for Alzheimer’s biomarker diagnostic device

DiamiR announced in a March 15 news release that it was awarded a $2.75 million Small Business Innovation Research (SBIR) Phase IIB grant from the National Institute on Aging and the National Institutes of Health. The grant is going toward supporting the development of DiamiR’s targeted diagnostic technology that analyzes brain-enriched microENA biomarkers in plasma to detect Alzheimer’s disease. The grant will stretch over a 3 year period and builds on to the company’s earlier studies that received SBIR Phase I and SBIR Phase II grants.

5. Flowonix and Cerebral Therapeutics launch clinical trial

Flowonix and Cerebral Therapeutics announced that the first patients of its clinical trial have had the Prometra implanted, according to a March 14 news release. The clinical trial, called ADDRESS, is the first multi-center dose ranging clinical study that evaluates intracerebroventricular (ICV) delivery of the drug valproate in patients who have focal seizures and have a temporal lob onset with to without secondary generalization. The study includes 9 patients who will undergo this treatment and will receive the valproate from the Flowonix Prometra II Programmable Pump.

6. Bonesupport extends U.S. bone Cerament distribution deal

Bonesupport has extended the terms of its U.S. distribution agreement with Zimmer Biomet, according to a March 14 news release. Zimmer Biomet will continue to have exclusive rights to Sonesupport’s Cerament Bone Void Filler designed for orthopedics, trauma and foot and ankle indications in the U.S.

7. Ortho Clinical Diagnostics and Astute Medical extend partnership

Ortho Clinical Diagnostics has expanded its agreement with Astute Medical for its NephroCheck Test distribution, according to a March 13 news release. The NephroCheck Test is a biomarker-based test that asses the risk for acute kidney injury. This new agreement gives Ortho Clinical Diagnostics the distribution rights in more European countries. Astute Medical gave Ortho a license to develop and market the NephroCheck Test in the U.S. and certain countries in Europe in 2014.

Here’s what we missed last week.