INVO Bioscience Archives - Medical Design Sourcing

Invo wins FDA clearance for expanded InvoCell labeling

Invo Bioscience (Nasdaq:INVO) announced that the FDA granted 510(k) clearance to expand the labeling on its InvoCell device.

Sarasota, Florida-based Invo’s InvoCell indication now includes a five-day incubation period. Data supporting this clearance demonstrated improved patient outcomes for the device, which previously had a three-day incubation period.

The company designed InvoCell to allow fertilization and early embryo development to take place in vivo within the woman’s body. InvoCell won FDA de novo approval in November 2015 and launched in the U.S. in April 2016.

“This is a momentous day for Invo as the FDA has provided clearance for us to expand our labeling to cover a 5-day incubation period for InvoCell,” said Steve Shum, CEO of Invo. “This has been a multi-year effort to demonstrate InvoCell’s ability to improve patient outcomes using a longer incubation period, similar to conventional IVF results. We believ…

Invo Bioscience increases offerings in Canada through acquisition

Invo Bioscience (OTCQB:IVOB) announced today that it acquired a Canadian-based entity formed to offer its InvoCell platform in Canada.

The unnamed entity previously completed a number of important procedures and the documentation required to establish InvoCell within clinical operations in Canada, according to a news release. The acquisition included a $25,000 cash payment and 30,000 shares of common stock, plus an incentive provision under which additional common stock shares can be issued for each clinic established that employs the Invo procedure in which the original Candian entity shareholders provide support.

Sarasota, Florida-based Invo Bioscience plans to leverage the newly acquired entity to advance the distribution of the Invocell infertility treatment platform and take advantage of the existing product registration in the Canadian market. The company will also initiate the development of joint ventures to establish Invo Centers within the Canadian ma…

Invo Bioscience names chief financial officer

Invo Bioscience (OTCQB:IVOB) today announced that it has appointed Andrea Goren as chief financial officer.

Goren has more than 27 years of experience in finance. He has held a number of leadership roles at Phoenix Group, Shamrock Group and Madison Capital Group.

“We are pleased to appoint a financial executive the caliber of Andrea Goren as chief financial officer of INVO Bioscience. Andrea has been serving INVO over the past year in a consulting capacity and thus is familiar with the operations of the company, including many within the finance function,” CEO Steve Shum said in a news release. “As he takes over as our permanent CFO, he will continue to interface with our current outside CFO consulting firm to assure a seamless transition. His well-rounded skill set will benefit INVO as we continue to successfully execute on our strategic business plan, including the operational launch of our various company-owned INVO clinics set for the seco…

Invo Bioscience raises $2.1

Invo Bioscience (OTCQB:IVOB) filed an SEC Form D to confirm the sale of more than $2.1 million in equity, debt and other warrants/options.

The Sarasota, Fla.-based company made its first sale in the new notice on May 15, collecting the more than $2.1 million from eight investors so far. The offering is not being made in connection with a business combination transaction, like a merger or acquisition.

Invo Bioscience still has almost $1.4 million remaining to sell in the offering that is set to total $3.5 million. Separately, the company currently owes $128,000 in sales commissions related to the offering, according to the filing.

The company develops the InvoCell system for incubating eggs and sperm during fertilization during early embryo development, operating within a woman’s body.