Manny Villafana: A medical device legend from one era looking to also thrive in this one
On the road to pursue his next endeavor, Manny Villafana shared about why after decades in the medical device industry, he's still at it.
Cardiac medical device company files second IDE after first was turned down
Last September, cardiac medical device company, Kips Bay Medical announced that the Food and Drug Administration had essentially rejected its investigational device exemption application for a pivotal study because it needed additional information. On Wednesday, Kips Bay Medical, based in Minnesota, announced that FDA had responded positively to the additional information it provided paving the […]
Understanding EGPA: The Role of Eosinophils and Advancements in Treatment Options
FASENRA® (benralizumab) injection, for subcutaneous use, 30 mg is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). FASENRA provides a treatment option for HCPs to consider when managing this challenging disease.
Cardiac medical device company Kips Bay Medical promotes CFO to COO
Cardiac medical device company Kips Bay Medical (NASDAQ:KIPS), based in Minnesota, has promoted chief financial officer Scott Kellen to chief operating officer. Kellen still retains his CFO title and responsibilities. Kellen joined Kips Bay Medical in February 2010, before which he was the CFO at Transoma Medical. “Scott has been an instrumental part of our […]
Cardiac medical device firm Kips Bay Medical hurt by lower reimbursement
Kips Bay Medical (NASDAQ:KIPS) FDA struggles trickled into its financials, as the company said a lack of clinical data has cut into sales. That clinical data is what the FDA called for months back when it set the company’s U.S. approval strategy back. Kips says it has gathered more data and is on track to […]
Cardiac medical device firm Kips Bay completes $20 million investment
Kips Bay Medical (NASDAQ:KIPS), which one month ago went public with its recent struggles with the U.S. Food and Drug Administration, has made a deal that secures the company up to $20 million in fresh investment. Under the terms of the agreement, the Illinois-based Aspire Capital Fund will purchase up to $20 million in Kips […]
Kips Bay Medical working to gain foothold in Europe but not there yet
Kips Bay Medical is moving closer to its IPO (it now plans to raise $21.2 million instead of $57.5 million). But in the meantime the company carries on, trying to get a foothold in Europe. It won approval to sell its eSVS Mesh vein support system in Europe in May, but had only sold 165 units in its first seven months after approval.
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Orthodpedic firm Tornier Inc. files for $205 million IPO
Tornier Inc. is planning to test the choppy waters of Wall Street with an estimated $205 million initial public offering, according to documents filed with the Securities and Exchange Commission. The orthopedics firm in Edina, Minn., which specializes in devices to treat injuries to extremities and small bones, is the third local medical device company […]
Kips Bay Medical raising $5 million for bypass surgery aid
The company is the latest venture by Manny Villafana, dubbed everything from The Cardiac Cahuna to a Living Legend of Medicine for founding St. Jude Medical as well as a series of other heart device and biotech companies since the 1970s.