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Sientra’s “Stand-By” Series C Shows How To Eliminate Late-Stage Risk

Breast-implant start-up Sientra recently raised a $65 million Series C round at a time when venture capital for medtech is scarce, particularly for mid-stage companies pushing toward important milestones. Using a new kind of “stand-by” financing, it was ready to hit the ground running upon the recent FDA approval of its breast implants.

In this era of economic uncertainty, more and more venture capitalists are looking to minimize the risk of investing. This climate of caution is driving early-stage investors to invest in later-stage companies where the travel time to regulatory approval and commercialization is shortened by years. But even investing in late-stage companies with big ticket clinical and regulatory costs comes with risk ( well, in most cases anyway. The investors in Sientra Inc.’s $65 million Series C round managed to all but eliminate the risks associated with investing in a company awaiting approval from the Food and Drug Administration.

Abingworth Management Inc. led the financing, and all of the company’s inside investors returned, including Clarus Ventures and OrbiMed Advisors....

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

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FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By Elizabeth Orr

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

After Thought-Control Demo, Synchron Plans Pilot Study With Upgraded BCI On Path To Pivotal Trial

 
• By Marion Webb

Synchron is preparing a pilot study of its fully wireless, second-gen brain-computer interface after an ALS patient controlled an iPad solely by thought. If all goes as planned, Synchron’s BCI will move into pivotal trials in 2026.

Apreo Health Raises $130M, First Patient Treated In US Clinical Trial

 
• By Natasha Barrow

Apreo Health CEO Karun Naga talks to Medtech Insight about the company’s intentions for its Series B funding. The Breathe-3 clinical trial and early commercialization activities, involving physician education, are top priorities.