Kips Bay Medical (NASDAQ:KIPS) FDA struggles trickled into its financials, as the company said a lack of clinical data has cut into sales.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
In the quarter ended Dec. 31, the company, which went public in February, saw sales drop to $94,000 from $116,000 in the same quarter of 2010. Net loss widened to $1.1 million, or 7 cents per diluted share in the fourth quarter, compared with a loss of $803,000, or 6 cents per diluted share, in the same year-ago period. For the year, net sales increased to $252,000, up from $223,000 in 2010. But the company had a net loss of $4.3 million, or 27 cents per diluted share, compared to a net loss of $10.9 million, or 81 cents. (The 2010 loss was disproportionately large because it included a $5 million noncash charge for the first milestone payment to Medtronic, from which Kips Bay Medical licenses its mesh technology. It also includes a $2.3 million noncash charge for an increase in the estimated fair value of an investor stock purchase option liability.)
“The decrease in net sales during the current quarter is due to limited availability of reimbursement to hospitals moderating the usage of the company’s eSVS Mesh” device, according to a news release from Kips Bay Medical. “The company expects sales to continue at modest levels until additional clinical study data is available.”
Additional data is what the U.S. Food and Drug Administration has been seeking in order to grant Kips Bay Medical an IDE or investigational device exemption for the eSVS Mesh device, which supports leg veins grafted to the heart during coronary artery bypass surgery.
In announcing the company’s financial results for the year, Kips Bay Medical also updated investors and shareholders about the status of talks with regulators.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The Company has gathered additional information on the eSVS MESH to address questions raised by the FDA in the past year. This data includes clinical results from a retrospective study of patients implanted with commercially available eSVS MESH devices at the American Hospital in Dubai, UAE and follow-up angiograms performed on patients from its original international trial. The Company intends to provide the additional information to the FDA as a Pre-IDE submission which allows the FDA to consider the adequacy of the additional information. Upon the completion of this review, the Company intends to submit an IDE application requesting approval for the inclusion of up to four U.S. hospitals in its feasibility study currently planned in Europe. The Company expects to file this IDE submission in the summer of 2012. The FDA has 30 days to respond to an IDE application, and while there can be no assurance that the FDA will approve the application, the Company remains optimistic.
Meanwhile, while lagging in getting a regulatory go-ahead for a pivotal trial, Kips Bay Medical appears to be gaining ground in the realm of intellectual property. Several international and U.S. patents were granted to the company such that currently Kips Bay Medical has six patents worldwide: two in the U.S. and one each in Japan, Europe, Canada and South Africa.
