NEW HAVEN, CT, (June 4th, 2019) - Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO), announced that it has entered into an exclusive subcontracting manufacturing agreement with diagnostics manufacturing company Novamed for the production of Precipio’s proprietary IV-Cell media for an initial term of 3 years. The agreement will provide Precipio with large-scale production volume of the media, enabling Precipio to provide cytogenetics laboratories in the US and worldwide with IV-Cell media to meet their demand.
Novamed is one of only a few companies worldwide with both substantial and specific experience in the production of products similar to IV-Cell; and the manufacturing capabilities necessary to scale up production of the media in large volumes to meet customer demand, as anticipated by Precipio. Novamed’s extensive experience providing various reagents to companies such as Thermo Fisher and Abbott Laboratories, as well as favorable business terms reached, were all key to its selection as Precipio’s choice manufacturer.
The lengthy review and negotiation process was completed this week, following an extensive, in-depth technical, manufacturing and logistics due diligence, in which Precipio carefully evaluated Novamed’s capabilities to manufacture and deliver the IV-Cell media to Precipio’s specifications.
Laboratories conducting cancer diagnostics require cytogenetics testing as part of the diagnostic process of a biopsy. Part of the process entails a culturing media (a chemical) used to mimic the growth of cells outside of the body. The current media sold on the market comprises of a base media, to which other components are added based on the type of cell to be cultured; it also limits the process to the culturing of only one cell lineage at a time.
IV-Cell is a newly designed proprietary media that includes all components in one bottle, thereby enabling a laboratory to culture all four cell lineages simultaneously without having to select a specific cell lineage. This enables the lab to arrive at a more accurate diagnosis by ensuring that the correct cell lineage is cultured. Furthermore, it eliminates the need to purchase and mix the additional components based on the type of cell lineage to be tested, delivering significant operational and cost advantages to cytogenetics laboratories.
“The development and launch of a new media which will impact the diagnostic process, and subsequently the lives of tens of thousands of patients, is one that must be done carefully and correctly,” said Ilan Danieli, Precipio CEO. “The search for the right manufacturer was viewed as critical to the successful commercialization of our proprietary media and we are confident that in Novamed we have found the right partner.”
“We are excited to be working with Precipio to bring to market its novel media,” said Dr. Emil Katz, Novamed CEO. “Novamed has always prided itself on creating and delivering meaningful, patient-impacting products, and so IV-Cell fits our portfolio well.”
Novamed, Ltd. is a privately-owned Israeli life science company founded in 1995. Since its inception, Novamed has been committed to the development of innovative, proprietary diagnostic systems with worldwide marketing potential. Novamed combines user need for a particular application with a cost-effective product. Among Novamed products are numerous FDA-approved products sold in the US and worldwide; Novamed holds the ISO 13485 certificate required for medical device manufacturing. For more information, please visit www.novamed.co.il.
Precipio has built a platform designed to eradicate the problem of misdiagnosis by harnessing the intellect, expertise and technology developed within academic institutions and delivering quality diagnostic information to physicians and their patients worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment such as the Yale School of Medicine and Harvard’s Dana-Farber Cancer Institute, Precipio offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, please visit www.precipiodx.com.
Certain statements in this press release constitute “forward-looking statements,” within the meaning of federal securities laws, including statements related to ICP technology, including financial projections related thereto and potential market opportunity, plans and prospects and other statements containing the words “anticipate,” “intend,” “may,” “plan,” “predict,” “will,” “would,” “could,” “should,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the known risks, uncertainties and other factors described in the Company’s definitive proxy statement filed on April 19, 2019 , the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 and on the Annual Report on Form 10-K for the year ended December 31, 2018 as well as the Company’s prior filings and from time to time in the Company’s subsequent filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. All information in this press release is as of the date of the release and the Company does not undertake any duty to update this information, including any forward-looking statements, unless required by law.