Inspira Technologies
Kurta Law is investigating potentially unsuitable recommendations of Inspira Technologies stock to investors. When companies conduct a stock offering, they must disclose risks to investors in a prospectus filed with the SEC.
If you lost money on your investment in Inspira Technologies, you may be able to recover your losses by pursuing FINRA arbitration. Contact us at (877) 600-0098 or email info@kurtalawfirm.com to speak to one of our securities attorneys for free today.
What is Inspira Technologies?
According to the prospectus, Inspira Technologies Oxy B.H.N. Ltd. (IINN for shares, IINNW, warrants) researches and manufactures its proprietary Augmented Respiration Technology (ART), designed to elevate and stabilize patients’ oxygen saturation to prevent the need for mechanical ventilation.
The prospectus states that the company’s ART500 device consists of a dual lumen cannula (a tube) inserted into the patient’s jugular vein and an “extra-corporeal direct blood oxygenation unit.” Extracorporeal units are medical devices that perform treatment outside the body, typically by pumping blood out and returning treated blood to the patient.
At the time of Inspira Technologies’ prospectus, the ART500 had not been tested on human subjects and had not received approval from the FDA.
What are the Risks Associated with Inspira Technologies?
Given Inspira Technologies’ limited operating history and lack of experience successfully bringing medical devices to market, investors may have a difficult time evaluating the company’s prospects. It disclosed these and other risks in its prospectus.
Capital Deficit and Doubt as a Going Concern
Inspira Technologies had no market-ready products at the time of the prospectus and had focused entirely on developing its ART500. The company states that it has incurred losses since its inception, and had an accumulated deficit of approximately $11.8 million as of December 31, 2020.
As a result, the company’s audited financial statements for the period ending December 31, 2020, include a disclosure of “substantial doubt” about the company’s ability to continue as a going concern.
The prospectus also states that: “Even if this offering is successful, we will need to raise substantial additional funding.” If this funding is in the form of securities offerings, existing investors may find their ownership diluted.
Potential Volatility and Limited Trading Market
The prospectus warns that “the market price of our securities may be highly volatile,” and that an active trading market is not guaranteed to follow this offering. Price volatility can make it difficult for investors to sell their shares for a profit, and an inactive market could limit their ability to sell at all.
These factors could also limit the company’s ability to raise additional funds by selling shares in the future.
Dependence on Success of ART500
As the company’s singular product candidate as of the prospectus, the ART500’s success is a major factor in the company’s financial future. Success depends on Inspira Technologies’ ability to gather financial resources, achieve regulatory clearance, establish marketing and distribution channels, and compete against existing respiratory treatments, among other challenges.
The company also relies on third-party suppliers and manufacturers to produce and assemble the components of the ART500. Issues in the manufacturing process, such as insufficient production or quality control issues, could have a negative effect on Inspira Technologies’ business.
Compliance with International Regulations
As an Israeli company intending to market its products internationally, Inspira Technologies must comply with various countries’ laws and regulations concerning medical devices, securities offerings, and other aspects of its business. This includes seeking FDA approval for the ART500 and complying with the EU Medical Devices Directive, as well as complying with state-level regulations.
Inspira Technologies must also keep up with changes to any applicable laws and regulations. Failure to comply with regulatory requirements could result in financial penalties, product recalls, or criminal prosecution.
Aegis Capital Corp. Underwriting
Investors should know that Aegis Capital Corp. served as the underwriter for this offering. Underwriters take on risk in exchange for a fee, which could motivate certain investment banks to underwrite investments that pose too much risk for the average retail investor. Additionally, brokers may have conflicts of interest when they recommend shares that are underwritten by an affiliate of their brokerage firm.
Do You Have Concerns Related to Your Shares of Inspira Technologies?
If you lost money on your investment in CN Energy Group, our experienced securities attorneys may be able to help you get a fair settlement. Kurta Law attorneys have experience with FINRA arbitration and achieving fair settlements for clients. Call (877) 600-0098 or email info@kurtalawfirm.com.