DTW Podcast: Arboretum’s Walker recalls early persistence in entering medtech

In this week’s DeviceTalks Weekly Podcast, Nicole J. Walker, the newest managing partner at Arboretum Ventures, recalls the persistence that landed her first job in the medical device industry. This inspiring story – complete with explosion – demonstrated how Walker has been able to build a career in industry – working for Guidant and Abbott – in investing at Onset, Baird Venture Partners and now Arboretum Ventures.

 



DeviceTalks by MassDevice · How Arboretum Venture’ Walker learned early in her medtech career to not take “No” as an answer
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Vicarious Surgical opens new corporate HQ in Massachusetts

[Image courtesy of Vicarious Surgical]Vicarious Surgical announced today that it established a new corporate headquarters in Waltham, Mass.

The company, which seeks to bring robotics and virtual reality to minimally invasive surgery, said in a news release that the new headquarters will expand its core business functions and house approximately 250 employees.

With what the company describes as a “rapidly growing team,” Vicarious leased a 42,000 square-foot facility at 78 Fourth Avenue in Waltham. The facility will house a full-scale operating room for robotics testing, along with research and development capabilities and company operations.

Vicarious Surgical said it is also expanding its manufacturing capabilities with the development of a comprehensive manufacturing facility, including a clean room, within the new headquarters.

In April, the surgical robotics company announced that it would go public through a $1.1 billion merger with D…

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Supreme Court rejects Medtronic bid to overturn spine surgeon’s royalties win

The front of U.S. Supreme Court in Washington, D.C. (Adobe stock photo)

Medtronic (NYSE:MDT) lost its bid Monday to have the U.S. Supreme Court toss a decision awarding $112 million in royalties to an Indiana spine surgeon-turned-inventor.

The court declined to hear a petition by Medtronic to overturn an appeals court decision that allowed the jury’s award to Dr. Rick Sasso to stand. Sasso won the royalties decision in Indiana state court in 2018, five years after first claiming in a lawsuit that the company shorted him on their royalties deal for the Vertex cervical spine system he helped develop.

Get the full story on our sister site, Medical Design & Outsourcing.

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Onkos Surgical wins FDA clearance for BioGrip 3D-printed implant

Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology.

Parsippany, N.J.-based company designed BioGrip to address the clinical challenge of aseptic loosening in musculoskeletal oncology and complex orthopedic limb salvage surgery. It helps provide bone ingrowth at the bone-implant interface.

Get the full story on our sister site, Medical Design & Outsourcing.

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Onkos Surgical wins FDA clearance for BioGrip 3D-printed implant

Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology.

Parsippany, N.J.-based company designed BioGrip to address the clinical challenge of aseptic loosening in musculoskeletal oncology and complex orthopedic limb salvage surgery. It helps provide bone ingrowth at the bone-implant interface.

The 3D-printed porous structure, nano HA treated design is one of two interchangeable collar designs, according to the company. The FDA clearance also includes an oval-shaped collar design for greater contact in distal femoral replacements where subsidence is a common challenge.

“This is a historic day for Onkos Surgical. When we started the company, we set out to deliver innovation that would directly address the long-established clinical challenges of limb salvage surgery – soft-tissue attachment, implant loosening, and infection. In the past six months, we have made significant progress by la…

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Avania acquires IMARC

Avania today said it has acquired medical device clinical research IMARC for an undisclosed amount.

Strongsville, Ohio-based IMARC is a full-service clinical research oversight company that offers monitoring, auditing, safety, data management and training.

Get the full story on our sister site, Medical Design & Outsourcing.

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Avania acquires IMARC

Avania today said it has acquired medical device clinical research IMARC for an undisclosed amount.

Strongsville, Ohio-based IMARC is a full-service clinical research oversight company that offers monitoring, auditing, safety, data management and training.

“At Avania, we are focused on building a high-quality, full-service specialist medical technology CRO with global reach,” Avania CEO Sapna Hornyak said in a news release. “We are delighted to welcome the IMARC team, with whom we have had the pleasure of collaborating for some time. They bring a great commitment to client service and outcomes and allow us to offer our clients additional depth and strength in the United States, complementing our existing global operations perfectly.”

Through the deal, IMARC’s clients will gain access to Avania’s extended international footprint in the EU and Australia. Netherlands-based Avania will also provide its biostatistics, strategic consulting, regulat…

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Pear Therapeutics to go public via merger with SPAC

Pear Therapeutics announced today that it entered into a definitive business combination agreement with SPAC Thimble Point Acquisition Corp.

Boston-based Pear Therapeutics’ combination with the special purpose acquisition company (SPAC), whose management team is associated with the Pritzker Vlock Family Office, will result in a combined company named Pear Holdings Corp. The companies expect to complete the merger in the second half of this year.

Pear Holdings Corp. will be led by Pear’s current management team, with the combined company’s common stock set to be listed on the Nasdaq market under the ticker “PEAR,” according to a news release.

The business combination values the combined company at a pro format equity value of approximately $1.6 billion. Pear Holdings Corp. is expected to have approximately $450 million in net cash on its balance sheet upon the transaction, including approximately $400 million in gross proceed…

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Medtronic announces first clinical procedure with its Hugo robot

Medtronic (NYSE:MDT) announced today that it completed the first patient procedure with the Hugo robotic-assisted surgery system.

Fridley, Minn.-based Medtronic said in a news release that urological surgeon Dr. Ruben Olivares performed the robotic prostatectomy on June 19 at Clínica Santa Maria in Santiago, Chile. The procedure marks the beginning of the Hugo RAS system patient registry, which will collect clinical data as the company seeks various global regulatory submissions.

“I’m proud to have performed the very first clinical procedure with the Hugo RAS system,” Olivares said in the release. “From the open console and modular platform to the instrumentation I know and trust, this innovative system is truly a partner in the OR. I feel energized by the possibility the Hugo RAS system brings to patients and clinicians and am honored to help pave the way for future surgeons, being able to offer a minimal invasive alternative on a regul…

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Glytec names Nausheen Moulana as chief technology officer

Cloud-based insulin management software developer Glytec announced today that it appointed Nausheen Moulana as its chief technology officer.

In the role of CTO, Moulana will be responsible for Glytec’s product and technology vision, strategy and execution. She will lead the company’s product development teams with focus on enhancements in provider workflows, electronic health record (EHR) integrations, mobile apps and support for other diabetes technologies.

Get the full story at our sister site, Drug Delivery Business News.

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First oral blood thinner for children wins FDA approval 

FDA has approved Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) oral pellets for children with venous thromboembolism who are between three months and under 12 years old.

The indication stipulates that children receiving Pradaxa have received prior treatment with an injectable blood thinner given by injection for at least five days.

FDA has also approved Pradaxa in capsule form to treat blood clots in patients eight years and older with venous thromboembolism. That approval also requires that the patients receive a prior injectable blood thinner for at least five days. FDA has also approved the use of Pradaxa to prevent recurrent clots in patients eight and older who finished treatment for their first venous thromboembolism.

Besides Pradaxa, there is no other approved oral blood thinner for children.

The drug first won FDA approval in 2010 to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation.

“The F…

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Why Janssen believes next-gen drug Tremfya can meet unmet needs in psoriasis and beyond

Two decades ago, psoriasis was a poorly understood condition. Treatment options for severe psoriasis included powerful immunosuppressant agents such as methotrexate and cyclosporin that can have significant side effects.

But the fact those immunosuppressant drugs were effective at treating psoriasis helped pave the way to use biologics to treat the condition. The experience “really taught us that psoriasis was an immunologic disease,” said Dr. Lloyd Miller, vice president, immunodermatology at Janssen Research & Development (NYSE:JNJ).

After researchers determined that psoriasis, which affects some 125 million patients worldwide, results from excess inflammatory cytokines, drug developers began to test the potential of inhibitors of tumor necrosis factor (TNF) and interleukin 17 (IL-17) in treating the disease.

FDA approved TNF blockers such as Janssen’s Remicade (infliximab) for psoriasis and psoriatic arthritis in the mid-2000s. IL-17A antagonists …

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