Agreement includes minimum purchase obligations upon product registration and approval
SARASOTA, Fla., May 16, 2022 — INVO Bioscience, Inc. (Nasdaq: INVO) (“INVO” or the “Company”), a commercial-stage fertility company focused on expanding access to advanced treatment worldwide with its INVOcell® medical device and the intravaginal culture (“IVC”) procedure it enables, today announced it has entered an exclusive distribution agreement with Onesky Holdings Limited (“Onesky”) for Mainland China (excludes Hong Kong, Macau and Taiwan).
Onesky will be responsible to register the product in the country, and upon government approval, will be obligated to purchase minimum quantities of INVOcell totaling approximately $14 million over the initial five-year term after approval. Customary additional terms and conditions apply, including term renewals.
“We are excited to enter this distribution agreement with Onesky to bring INVOcell to Mainland China,” commented Steve Shum, CEO of INVO. “China clearly represents a large addressable market opportunity for INVOcell, and as a result we have been diligent in our partnerships efforts to ensure we have the best partner to achieve success with. Following extensive due diligence, we believe Onesky has the unique capabilities necessary to drive adoption of INVOcell in China through their large network of OBGYNs and reproductive specialists which have relied upon Onesky for many years as a trusted vendor. We look forward to successfully completing product registration and deploying INVOcell within the China marketplace.”
According to reports, China has seen its infertility population grow to approximately 50 million with about one in six people of childbearing age facing fertility challenges – this is higher than the global average of one in eight people. Growing infertility together with forecasted population decreases were key to the Chinese government’s decision to put an end to the one-child policy that had been in effect for several decades, increasing the limit to two children in 2016 and to three children in 2018. China also has invested significantly in the domestic market for fertility services, which is the largest in the world in terms of annual treatment cycles.
About Onesky Holdings Limited
Onesky Holdings Ltd is the holding company focusing on R&D, Manufacturing, Distribution and After-Sales Service of RO medical equipment, all operated by its affiliates. Strategically located in Guangzhou City of China and legally incorporated in Hong Kong, the corporate office of Onesky manages the daily operation of a nation-wide distribution network, an ISO13485 compliant production facility as well as an R&D center. Their product portfolio includes Radiation Therapy Disposables, Imaging, Women’s Health, Rehabilitation, and Surgery.
With respect to distribution, OneSky’s is one of the largest suppliers of radiation therapy third party products in China, selling both domestic and imported medical devices to 150+ 3A hospital users and more than 200 regional sub-distributors all over China. OneSky’s own thermoplastic products are also distributed to 15+ countries in Asia and Europe. All products are NMPA, FDA and CE approved.
The Parent company of Onesky is Biomedic Medical Group. Biomedic Medical Group is an international MedTech holdings company incorporated in 2002 in Hong Kong, with business arms covering both Radiation Oncology and minimal invasive ablation of tumors and veins. The Radiation Oncology business is operated by “Onesky Holdings Limited”, while the minimal invasion arm being ‘Minimax Medical Limited’. Minimax operates an affiliated R&D centre in the States, and a high frequency device production facility in Nanjing City of China to conduct independent OEM businesses and self-brands products distributed by Minimax itself, among other imported minimal invasive products from the US and EU.
Biomedic also has a separate investment arm that invest in pre-IPO equity of European companies covering the field of surgical robots, mRNA and volatile organic compounds.
About INVO Bioscience
We are a commercial-stage fertility company dedicated to expanding the assisted reproductive technology (“ART”) marketplace by making fertility care accessible and inclusive to people around the world. Our primary mission is to implement new medical technologies aimed at increasing the availability of affordable, high-quality, patient-centered fertility care. Our flagship product is INVOcell®, a revolutionary medical device that allows fertilization and early embryo development to take place in vivo within the woman’s body. This treatment solution is the world’s first intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early embryo development. This technique, designated as “IVC”, provides patients a more natural, intimate, and more affordable experience in comparison to other ART treatments. We believe the IVC procedure can deliver comparable results at a fraction of the cost of traditional in vitro fertilization (“IVF”) and is a significantly more effective treatment than intrauterine insemination (“IUI”). Our commercialization strategy is focused on the opening of dedicated “INVO Centers” offering the INVOcell® and IVC procedure (with three centers in North America now operational), in addition to continuing to distribute and sell our technology solution into existing fertility clinics. For more information, please visit www.invobio.com.
Safe Harbor Statement
This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE INVO Bioscience, Inc.