Invo Bioscience (OTCQB:IVOB) has received FDA approval to begin a clinical trial of its modified InvoCell system. The trial will measure InvoCell’s effectiveness in achieving fertilization, implantation, embryo development, clinical pregnancy and live birth after 5 days of continuous vaginal incubation, according to the Sarasota, Fla.-based company. The device is currently cleared for 3-day use. The […]
Invo Bioscience signs Indian distribution deal
Invo Bioscience (OTCQB:IVOB) recently announced that it has inked a joint venture with Medesole Healthcare and Trading Private Limited to market and distribute the InvoCell in vivo fertility system in India. The joint venture will be called Medesole Invo Bioscience India Private Limited and is expected to open and operate dedicated InvoCell clinics only in India, […]
Invo Bioscience signs European distribution deal
Invo Bioscience (OTCQB:IVOB) announced that it entered into commercialization agreements covering Turkey and Jordan to support the company’s expansion into Eurasia. The commercialization agreements are in place to spread the Lakewood Ranch, Fla.–based company’s InvoCell in vivo fertility system to the Eurasia area. Invo Bioscience said research shows that an estimated 15% to 20% of the […]
Invo Bioscience wins CE Mark for InvoCell fertility device
INVO Bioscience (OTCQB:IVOB) said last week that it received CE Mark approval for its InvoCell culture and retention device as an alternative to traditional in vitro fertilization treatment. InvoCell won FDA de novo approval in November 2015 and was launched in the U.S. in April 2016. Currently, it is distributed throughout the U.S. under an $8 […]
Nelipak names Roger Prevot CEO | Personnel Moves, Oct. 16, 2019
Nelipak Corp. said last week that Roger Prevot will take over as CEO, following the retirement of current CEO Michael Kelly. Kelly was in charge when private equity giant Kohlberg bought Nelipak for an undisclosed amount July 2. Kelly is retiring after overseeing the deal and positioning the company for the next phase of its […]
INVO Bioscience prices $13m offering
INVO Bioscience (OTCQB:IVOB) yesterday registered a common stock offering of more than $13 million, according to a regulatory filing. The Lakewood Ranch, Fla.-based company is putting up nearly 41 million shares of its common stock for close to $13.1 million. There are currently nearly 39 million outstanding shares, according to the filing. They are traded […]
INVO Bioscience touts two women’s ability to carry the same baby
INVO Bioscience today announced that a child had been born to a same-sex couple in which both partners were able to carry the baby in separate phases of the pregnancy. The couple, Bliss and Ashleigh Coulter of Mountain Springs, Texas, welcomed their son, Stetson, in late October. The women and their doctors used INVO Bioscience’s […]
Invo Bioscience launches InvoCell in US
INVO Bioscience said today it launched its InvoCell intravaginal culture infertility treatment system in the U.S., starting in Texas through the Center for Assisted Reproduction. INVOcell is designed for incubating eggs and sperm during fertilization during early embryo development and operates within a woman’s body, unlike in vitro fertilization which takes place in a laboratory, the company […]
INVO Bioscience wins FDA de novo approval for InvoCell
INVO Bioscience said yesterday it won FDA de novo approval for its INVOcell intravaginal culture infertility treatment system. The company said it is the 1st intravaginal culture system with marketing clearance in the U.S. INVOcell is designed for incubating eggs and sperm during fertilization during early embryo development and operates within a woman’s body, unlike in […]
Medtronic wins 510(k) for surgical sealer | Regulatory Roundup
Medtronic (NYSE:MDT) won 510(k) clearance from the FDA for the Aquamantys surgical sealer it acquired when it paid $480 million for Salient Surgical Technologies last year.
Geron’s exit from stem cell business means opportunity for InVivo, others
