▸ Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.· ● ● 2 ▸ The trading price of our common stock has been and is likely to be volatile and to fluctuate substantially, which could result in substantial losses for purchasers of our common stock.· ● ● 2 ▸ We do not intend to pay cash dividends on our common stock in the foreseeable future.· ● ● 2 ▸ group Minimum Bid Price Requirement· ● · 1 ▸ group Minimum Stockholder Equity Requirement· ● · 1 ▸ PRC regulations and policies. Failure to file as required could subject us or our controlling stockholders to fines and penalties, which· ● · 1 ▸ An active trading market for our common stock and warrants may not develop and you may not be able to resell your shares at or the purchase price, if at all.● · · 1 ▸ Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment.● · · 1 ▸ Fluctuation in exchange rates could have a negative effect on our results of operations and the value of an investment in the Company.● ● · 2 ▸ Holders of the warrants have no rights as a common stockholder until they acquire our common stock.● ● · 2 ▸ If we are not able to comply with the applicable continued listing requirements or standards of The Nasdaq Stock Market, Nasdaq could delist our common stock.● ● · 2 ▸ It may be difficult for overseas regulators to conduct investigations or collect evidence within China.● ● · 2 ▸ On March 6, 2024, the Nasdaq Hearing Panel granted the Company a temporary exception to regain compliance with the Minimum Bid Price Rule until April 25, 2024.● · · 1 ▸ Restrictions on foreign currency may limit our ability to receive and use our revenue effectively.● ● · 2 ▸ Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits.● · · 1 ▸ The trading price of our common stock and warrants may be volatile, and you could lose all or part of your investment.● · · 1 ▸ The warrants may not have any value.● ● · 2 ▸ Uncertainties in the interpretation and enforcement of Chinese laws and regulations could limit the legal protections available to us.● ● · 2 ▸ Warrants are speculative in nature.● ● · 2 ▸ We may be subject to regulatory and other risks if we were to operate Variable Interest Entities in China● ● · 2 ▸ We may redeem unexpired warrants prior to their exercise at a time that is disadvantageous to holders, thereby making such warrants worthless.● ● · 2 ▸ We plan to conduct decentralized clinical trials for the Gen-3 device in the U.S. and have consulted the FDA as part of the pre-submission meetings.● ● · 2 ▸ We will incur significantly increased costs as a result of operating as a company whose common stock is publicly traded in the United States, and our management will be required to devote substantial time to new compliance initiatives.● · · 1 ▸ The approval of the China Securities Regulatory Commission, and other compliance procedures may be required in connection with any offering we may make and, if required, we cannot predict whether we will be able to obtain such approval.● · ● 2 rw ▸ Any failure by any of our existing or future products that obtain regulatory approval to achieve market acceptance or commercial success would have a material adverse effect on our business prospects.● ● ● 3 ▸ Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions and matters submitted to stockholders for approval.● ● ● 3 ▸ Coverage and adequate reimbursement may not be available for our current or future products, which could make it difficult for us to sell profitably, if approved.● ● ● 3 rw ▸ If equity research analysts do not publish research or reports, or publish unfavorable research or reports about us, our business or our market, our stock price and trading volume could decline.● ● ● 3 ▸ If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.● ● ● 3 ▸ If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our products, which would harm our business.● ● ● 3 ▸ If we engage in future acquisitions or strategic collaborations, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.● ● ● 3 ▸ If we experience delays in obtaining approval or if we fail to obtain approval of our products, the commercial prospects for our products may be harmed and our ability to generate revenues will be impaired.● ● ● 3 ▸ If we experience delays or difficulties in the enrolment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.● ● ● 3 ▸ Our commercial success depends, in part, on our ability to develop, manufacture, market and sell our products and use our proprietary technologies without infringing the intellectual property and other proprietary rights of third parties.● ● ● 3 ▸ Our employees, independent contractors, principal investigators, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.● ● ● 3 ▸ Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.● ● ● 3 ▸ Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.● ● ● 3 ▸ Our products and product candidates may be subject to reclassification by the FDA, and a change in the classification may have an adverse impact on our revenues or our abilities to obtain necessary regulatory approvals.● ● ● 3 ▸ Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.● ● ● 3 ▸ Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or products.● ● ● 3 ▸ Recently enacted and future legislation may increase the difficulty and cost for us and our collaborators to obtain marketing approval of and commercialize our products and affect the prices we may obtain.● ● ● 3 ▸ group Risks Related to Doing Business in China● ● ● 3 ▸ group Risks Related to Our Business and Managing Our Growth● ● ● 3 ▸ group Risks Related to Our Dependence on Third Parties● ● ● 3 ▸ group Risks Related to Our Financial Position and Capital Needs● ● ● 3 ▸ group Risks Related to Our Intellectual Property● ● ● 3 ▸ Risks Related to Ownership of Our Common Stock and Our Status as a Public Company● ● ● 3 rw ▸ Risks Related to Regulatory Approval of Our Products and Other Legal Compliance Matters● ● ● 3 ▸ group Risks Related to the Commercialization of Our Products● ● ● 3 ▸ Risks Related to the Development of Our Products and Preclinical Program● ● ● 3 ▸ Significant disruptions of our information technology systems or data security incidents could result in significant financial, legal, regulatory, business and reputational harm to us.● ● ● 3 ▸ Success in preclinical studies or clinical trials may not be indicative of results in future clinical trials.● ● ● 3 ▸ The U.S. FDA, Chinese National Medical Products Administration and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.● ● ● 3 ▸ The medical industry in China is highly regulated and such regulations are subject to change which may affect approval and commercialization of our products.● ● ● 3 ▸ There may be difficulties in effecting service of legal process, enforcing foreign judgments or bringing actions in China against us based on foreign laws.● ● ● 3 ▸ Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could significantly harm our business.● ● ● 3 ▸ Uncertainties with respect to the PRC legal system could adversely affect us.● ● ● 3 ▸ We are an “emerging growth company” and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, our common stock may be less attractive to investors.● ● ● 3 rw ▸ We are subject to the risks of conducting business internationally.● ● ● 3 ▸ We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.● ● ● 3 ▸ We have identified material weaknesses in our internal controls over financial reporting, which could impair our ability to produce accurate financial statements on a timely basis.● ● ● 3 rw ▸ We may be subject to anti-monopoly concerns as a result of our doing business in China.● ● ● 3 ▸ We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.● ● ● 3 ▸ We may not be able to continue as a going concern if we do not execute our business plan or obtain additional financing in the future if necessary.● ● ● 3 ▸ We may not be able to protect our intellectual property rights throughout the world.● ● ● 3