March 17, 2023

January 31, 2023

ARLINGTON, Va., January 31, 2022The Medical Device Innovation Consortium (MDIC) released the “Landscape Report & Industry Survey on the Use of Computational modeling and Simulation (CM&S) in Medical Device Development”.  This new report from MDIC discusses the potential of CM&S to reduce product development costs, speed up time to market, and better serve patients with safe and effective medical devices. Case studies included in this report demonstrate tangible evidence of the value of CM&S to both industry and regulatory bodies such as the US Food and Drug Administration (FDA). The report also discusses current barriers to more widespread adoption and offers recommendations for future actions.

“The use of CM&S, or in silico methods, is well-established and rapidly increasing in the medical product development process, but still lags behind compared to other sectors like aviation or automotive industries. One of the goals for the MDIC CM&S program is to increase confidence in the use of CM&S in regulatory submissions.  MDIC aims to generate more discussion on this topic using this report and survey results included in it,” said Jithesh Veetil, Senior Director for Digital & Health Technology portfolio at MDIC.

Featuring insights from experts from industry and regulatory agencies, the report explores the evolution of the use of CM&S in the design and development of medical devices. The report is informed by comparing the results of two surveys that MDIC conducted nearly a decade apart – each of which had input from about 40 small, medium, and large medical device manufacturers, both domestic and international.

“This report validates the broad applicability—and true value—of computational modeling and simulation as a critical engineering discipline. Tangible cost, quality and performance improvements are being realized by the early adopters,” said Randall Schiestl, vice president, Research & Development, Global Technology, Boston Scientific and Chair of MDIC CM&S steering committee. “The report also highlights the need for continued work to increase both design and regulatory use across small, medium and large device developers.” The CM&S steering committee includes representatives from the FDA, National Institute of Health (NIH), and the medical device and diagnostics industry.

Case studies in this report represent areas such as orthopedics, cardiology, and digital twins, among others, and highlight the benefits of applying these methods in medical device design.  Combined with the analysis of the MDIC survey results, these examples help organizations justify utilization of computational modeling and simulation in product development.

Steven Levin, Sr. Director, Virtual Human Modeling, Executive Director, Living Heart Project agrees. “The MDIC survey shows the business impact of modeling and simulation is now well established and the FDA is recognized as a strong supporter. The landscape report adds important context and is a call to action for companies holding onto old R&D processes, highlighting MDIC’s important role as we enter the era of digital health.”

In addition to this landscape report on CM&S, MDIC’s CM&S program focuses on topics such as (1)  Augmenting clinical trials with virtual patients and external evidence methods to reduce the burden on human subjects;  (2) Translational research to bridge the gap between NIH and other publicly funded academic research human models – like blood damaging model, orthopedic models – with the aim to assess the credibility of simulation models for industry contexts of use and develop models with sufficient credibility into a Medical Device Development Tool (MDDT); and (3) Bootcamps specifically focusing on medical device CM&S for device manufacturers and regulatory professionals. A collection of MDIC resources across the total product lifecycle of medical devices that highlights the dynamic and evolving technology advancements in healthcare is available in the MDIC online Resource Library.

About MDIC:
The Medical Device Innovation Consortium (MDIC) is a public-private partnership that brings together representatives of the FDA, NIH, CMS, NIST, and other agencies, industry, non-profits, and patient advocacy organizations to improve the processes for development, assessment, and review of new medical technologies.

MDIC coordinates the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.

We are driving faster, safer, and more cost-effective innovation for patient benefit.

Todd West

December 15, 2022

MDIC’s new report surveys the role of 5G connectivity in current and future states of the healthcare continuum of care. The report highlights key challenges and knowledge gaps to help deliver the benefits of 5G in healthcare more safely to patients.


ARLINGTON, Va. – The Medical Device Innovation Consortium (MDIC), has released the Landscape Analysis of 5G in Healthcare report. This report, accompanied by a one-page overview on 5G Security Enhancements, details the role of 5G connectivity in the future state of medical devices utilizing the technology that will contribute to the continuity of care.

The report developed by MDIC’s 5G–Enabled Health Technologies Working Group highlights key challenges and knowledge gaps to deliver the benefits of 5G in healthcare more safely to patients. This report was championed by MDIC 5G Working Group members Dr. Omar Al-Kalaa, PhD, Staff Fellow FDA; Inhel Rekik, MS, CISM, Sr. Director, Product Security, Bracco Medical Technologies; and Mark Wehde, Chair, Mayo Clinic Engineering, Mayo Clinic, with contributions from experts in the sector.

The MDIC 5G–Enabled Health Technologies Working Group is comprised of leading experts from the FDA, United States Department of Veterans Affairs, academia, medical device industry, telecommunications sector, standards development organizations, and chipset and network equipment manufacturers. For this report, they convened to develop a better understanding of how 5G can improve patient safety across the entire continuum of care – from prevention through diagnosis, treatment, post-treatment monitoring, and beyond.

Key topics covered in the report include:

  • 5G-enabled simulation with extended reality (XR)
  • 5G-enabled robotics, remote surgical robots
  • Mobile units, remote care, and telemedicine
  • Supply chain and cost
  • Network coverage
  • Ongoing QoS monitoring
  • Communication Key Performance Indicators (KPIs)
  • Lack of evaluation methods for device functions enabled by 5G
  • Roles, responsibilities and service level agreements
  • Electromagnetic environment and wireless coexistence
  • 5G cybersecurity and privacy considerations.

“MDIC convened over 150 global subject matter experts from various stakeholder groups to establish the common understandings of the technical and operational requirements for
5G-enabled devices, which in turn contribute to the safety and effectiveness of the device as well as accelerating patient access to this technology,” said Jithesh Veetil, PhD, Senior Program Director, Digital Health & Technology, MDIC.

Advances in wireless technologies can contribute to continued technical advancements in healthcare delivery.  In this rapidly evolving environment, technology moves quickly, especially with a healthcare model moving to more remote, virtual care of patients. 5G plays a significant role in this care evolution.

“It was a truly rewarding experience to work with subject matter experts from around the globe through MDIC on the 5G landscape analysis.  5G technology will enable advanced home healthcare as well as allow hospitals including those in rural areas to provide cutting edge procedures and therefore narrowing health disparities among less favored communities while allowing them access to their highest level of care,” said Inhel Rekik.

“5G in healthcare advancements are accelerating device innovation and will allow us to treat, diagnose, and track patient health anywhere the patient is. Health management solutions that aren’t tied to a physical location such as a hospital, clinic, or home will fundamentally change how we provide healthcare, who provides healthcare, and most importantly, it will democratize who has access to healthcare. The two publications from MDIC will be excellent resources for anyone interested to learn more about 5G in healthcare,” said Mark Wehde.

In addition to Landscape Analysis of 5G in Healthcare and MDIC 5G Working Group released “5G Communication in Healthcare: Background, Landscape, and Use Cases Webinar” in August 2022.  A collection of MDIC resources across the total product lifecycle of medical devices that highlights the dynamic and evolving technology advancements in healthcare is available in the online Resource Library.


About MDIC

The Medical Device Innovation Consortium (MDIC) is a public-private partnership that brings together representatives of the FDA, NIH, CMS, NIST, and other agencies, industry, non-profits, and patient advocacy organizations to improve the processes for development, assessment, and review of new medical technologies.

MDIC coordinates the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.

We are driving faster, safer, and more cost-effective innovation for patient benefit.



Todd West

December 6, 2022

ARLINGTON, VA (BUSINESS WIRE)—The Health Economics and Patient Value (HEPV) initiative at the Medical Device Innovation Consortium (MDIC) has released the white paper, How Can Patient Preference Information Be Used in Payer Coverage Decisions and Health Technology Assessment?

As patients become more engaged with their care, healthcare stakeholders want to understand how to better incorporate patients’ wants and needs into their own processes. In the development of this technical paper, MDIC set out to understand how to incorporate patient preference information (PPI) in coverage decision making by payers and health technology assessment (HTA) organizations. It is the first MDIC resource focused specifically on awareness of patient preference and methods as a tool for payers and the medical device industry.

This MDIC initiative seeks to encourage the use of patient preference information by clarifying the standards and role of generating this data and presenting it in a more consistent, systematic format. “This report can serve as a resource for payers and health technology assessment organizations’ decision-making process. This is especially true for patients with diseases associated with shortened lifespans, high-cost impact, serious complications, and those with unmet medical needs,” said Harry Kotlarz, Assistant Vice President of Health Economics and Patient Value at MDIC.

MDIC sponsored a series of interviews with representatives from seven organizations including the Centers for Medicare and Medicaid Services (CMS), commercial payers, integrated delivery networks, and health technology assessment organizations. A Working Group comprised of 18 members from the medical device industry, patient organizations, and regulatory agencies provided input for the interview questions.

“This report confirms that payers want to hear a diverse and representative patient perspective. Quantitative analyses of patients’ preferences, when done right, can fill an important evidence gap for payers.” Barry Liden, Director of Public Policy at USC Schaeffer Center, and former Working Group leader.

The report highlighted how patient preferences and conventional clinical outcomes assessment must be integrated to provide robust means of evaluating what will be more acceptable to patients and increase the likelihood of favorable outcomes. This white paper helps guide firms to benchmark, select, and structure a roadmap aligned with their company’s business and technical priorities.

About MDIC
The Medical Device Innovation Consortium (MDIC) is a public-private partnership that brings together representatives of the FDA, NIH, CMS, NIST, and other agencies, industry, non-profits, and patient advocacy organizations to improve the processes for development, assessment, and review of new medical technologies.

MDIC coordinates the development of methods, tools, and resources used in managing the total product life cycle of a medical device to improve patient access to cutting-edge medical technology.

We are driving faster, safer, and more cost-effective innovation for patient benefit.


Todd West

August 23, 2022

August 8, 2022

Congratulations to Jithesh Veetil, PhD, awarded The CDRH Regulatory Science Excellence Award for for the External Evidence Methods (EEM) Framework Project. MDIC EEM Framework is a document intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Informed by a number of public forums and a survey of medical device manufacturers, the document catalogs different sources of external data and some of the traditional and novel statistical methods (Frequentist and Bayesian) applicable to the design and analysis of a clinical study in which external data play a role. Join Dr. Veetil at the JSM 2022 Conference for “Advancing Regulatory Science for Medical Devices and Medical Software Through Collaboration”, August 10, 2022 at 10:30 AM.

Learn more

August 8, 2022

Stakeholders seek tweaks to FDA’s voluntary improvement program guidance

Regulatory NewsRegulatory News
| 08 July 2022 | By Jeff Craven 3044 The US Food and Drug Administration (FDA) has received comments on its draft guidance on engaging with the Voluntary Improvement Program (VIP) through the Medical Device Innovation Consortium (MDIC), and device companies want to know more about how manufacturers can benefit from participating as well as how the program fits into existing regulatory programs.

FDA’s participation in the VIP means device manufacturers can be assessed by third party appraisers that provide feedback on strengths and areas for improvement as measured by a modified version of the best practices in the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system for the medical device industry across 11 practice areas. Data can then be de-identified and shared with FDA following an appraisal. (RELATED: FDA drafts guidance on medical device voluntary improvement program, Regulatory Focus 9 May 2022)

Site visits and analyses under the VIP are not regulatory inspections or audits, the agency said in the draft guidance, and the appraisers don’t collect evidence of regulatory findings or provide regulatory observations, including a rating or certification.

“Participating manufacturing sites who demonstrate sustained capability and performance, or improvements in the appraisal results, may benefit from several opportunities that the VIP offers, following FDA’s review of the site’s appraisal,” the agency wrote in the draft guidance.

The VIP is a permanent version of the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which FDA launched with MDIC in 2018 and was well received by a majority of participants in the pilot. (RELATED: FDA Details New Manufacturing Quality Pilot Program, Regulatory Focus 15 January 2018)

In their comments to the FDA, medical device company Medtronic proposed changing the wording in the description of the Medical Device Discovery Appraisal Program (MDDAP) to include “Governance, Implementation Infrastructure and Managing Performance and Measurement” rather than FDA’s proposed practice areas of “Estimating, Planning, and Configuration Management” because the former are three core practice areas, while the latter “may or may not be included in future appraisals.”

Medtronic also suggested FDA change how it describes the ISACA CMMI “to include that firms are encouraged to identify an appraisal scope that applies CMMI best practices to proactively identify opportunities for continuous improvement.”

“We recommend VIP continues the focus on proactive identification of opportunities for improvement. Focusing on an increasing score year over year, could disincentivize firms who, today, are encouraging transparency during appraisals, and who are continuously looking at new areas to find additional opportunities for improvement,” they wrote. “This active search for improvement opportunities could temporarily result in a dip in scores.”

The device manufacturer suggested that a copy of any de-identified, aggregate information sent to the FDA should also be sent to the participating site. Medtronic recommended FDA make it clear that the appraisers don’t retain objective evidence collected during the site visit and remove terms like “rich dataset” that might imply quantitative data are being collected.

MDIC’s VIP Expansion Working Group
The working group responsible for modifying MDIC’s VIP Reappraisal Guidelines also provided a comment to FDA and suggested changes to align with the goals of the working group. They noted the “intent of the program is to shift from a compliance mindset and towards continuous improvement.”

To that end, they suggested adding language to the draft guidance that would allow manufacturers to participate in alternate engagement activities such as focused scope appraisal, continuous improvement event, or a capability benchmark appraisal instead of a standard appraisal when appropriate.

“The intent of this objective is to maintain the requirement for all sites to regularly engage with the program while balancing a core program feature allowing flexibility for individual participant need,” they wrote.

Becton Dickinson
Medical technology company Becton Dickinson asked FDA in their comment to clarify how the program affects surveillance inspections and pre-market inspections.

“The guidance explains how participating in VIP can offer ‘risk-based inspection planning’ and potentially reduce the cadence of inspection. However, it is unclear specifically how it could potentially spare a manufacturer from a surveillance and/or premarket inspection,” they wrote. “Removing the need for surveillance and/or premarket inspections could be major incentives of participating in VIP, thus, how these inspection types are specifically impacted by VIP participation should be explained.”

W. L. Gore & Associates
Manufacturing company W. L. Gore & Associates used their comment to FDA to ask for clarity on what the agency expects in terms of “sustained capability and performance” and whether a manufacturer needs to achieve a certain maturity level to qualify for risk-based inspection planning.

Gore also requested that Office of Health Technology (OHT) officers within CDRH’s Office of Product Evaluation and Quality (OPEQ) receive training on the VIP program and features, particularly the 30-Day Change Notice submission template. They cited their experience with inconsistencies in the program.

“For example, one OHT reviewer would not accept the template during the Pilot Program because the submission included biocompatibility data. They asked that the manufacturer instead submit as a ‘traditional 30-day Notice.’ Another OHT reviewer accepted the format under the program for a similar change,” they wrote.

Boston Scientific
Medical device manufacturer Boston Scientific provided a brief comment to FDA about the VIP, asking the agency to “avoid specifying that appraisals be required annually, but instead at least leave it open to possibility that the frequency be tailored as companies/sites remain active in the program year-on-year.”

Bringing Real-world Insight for Device Governance and Evaluation (BRIDGE) Coalition
The BRIDGE Coalition emphasized in their comment that the permanent program should be as flexible and responsive as the pilot program. “We support quality measures and believe VIP can prove to be beneficial for some products and manufacturers,” they wrote.

However, they questioned how the program would apply to participants with multiple sites. “The program, as currently structured, works well for small entities with one facility, or large manufacturers who only designate one or two sites for certification. The biggest gain for large manufacturers with multiple sites would be an enterprise program that could simultaneously cover more than one designated site,” they said.

The coalition also expressed concerns about third-party auditors. “It must be clear that this program exists outside of MDIC. Stated differently, participation in this program must be permitted outside of any specific third party. The benefits should be applicable to assessments done outside of the MDIC system,” they said. “Likewise, FDA should be open to assessments system similar to CMMI. FDA should not endorse one entity or one system for the VIP program.”

They also raised concerns about legal liability for products in the program, and the discoverability of information within the program in litigation. They suggested protections be built into the program that state submissions are not admissions of liability as well as limiting discovery of information from the program in third-party litigation. “Including similar protections in this pilot program will encourage participation and avoid disadvantaging companies that do partake in the pilot,” the group said.

The Coalition also suggested a “re-scoping” of the program to include pre-market incentives for 510(k) manufacturers in addition to pre-market approval (PMA) devices. “This program will have limited effect if it is limited to PMA devices. In many ways, this program may better fit into the Class II/special controls approach. We believe that FDA should seek public input on including Class II/special control in this program,” they wrote.

Draft guidance

© 2022 Regulatory Affairs Professionals Society.

This story was originally published by RAPS.

August 2, 2022

LA JOLLA, Calif.–(BUSINESS WIRE)– Calidi Biotherapeutics, Inc. (Calidi), a clinical-stage biotechnology company that is pioneering allogeneic cell-based platforms to revolutionize oncolytic virus therapies, is pleased to announce that City of Hope has received U.S. Food and Drug Administration (FDA) authorization to proceed with a phase 1 physician-sponsored clinical trial that will use Calidi’s licensed oncolytic virotherapy platform, NSC-CRAd-S-pk7 (NeuroNova), a cutting-edge therapeutic candidate comprising tumor-tropic neural stem cells delivering an oncolytic adenovirus selectively to tumor sites in patients with recurrent high-grade glioma (Calidi’s NNV-2 program).


The phase 1 physician-sponsored clinical trial will be an open-label, non-randomized, multicenter study. Once the phase 1 trial is funded, it will address the safety and tolerability of administering serial doses of NeuroNova in adult patients with recurrent histologically confirmed high-grade gliomas (WHO grade III or IV). Secondary endpoints will evaluate treatment efficacy, including progression-free and overall survival as well as any immune response to NeuroNova. This physician-sponsored study will be led by principal investigator Jana Portnow, M.D., Professor in City of Hope’s Department of Medical Oncology & Therapeutics Research and Co-Director of the Brain Tumor Program at City of Hope, a National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network. City of Hope is one of the largest cancer research and treatment organizations in the United States.


A previously completed phase 1 dose escalation clinical trial, in newly diagnosed glioma patients, of a single dose of NSC-CRAd-S-pk7 (NeuroNova) given as an adjunct to radiation and temozolomide (Calidi’s NNV-1 program) demonstrated that NeuroNova was well tolerated in the patient population and showed promising preliminary results of efficacy [J Fares et al, Lancet Oncology, 2021, 22(8):1103-1114].

“Worldwide, an estimated 270,000 people were diagnosed with a primary brain tumor in 2020, with a five-year survival rate of only 5%. Recurrent glioma patients have poor prognosis with a median survival of less than one year. Developing our drug candidate for this indication represents a significant milestone that will empower us to help more individuals survive this devastating disease,” said Calidi Biotherapeutics CEO and Chairman of the Board Allan J. Camaisa. “As Calidi undertakes this endeavor, we are pleased to have exclusive commercialization rights to this technology and thrilled to collaborate with two scientific trailblazers who have worked together on this project for over a decade: Dr. Karen Aboody, Professor in the Department of Stem Cell Biology and Regenerative Medicine, Scientific Leader of the Neuro-oncology Disease Team at City of Hope, and Dr. Maciej (Matt) Lesniak, Chair of the Department of Neurological Surgery, at Northwestern University Feinberg School of Medicine.”

“Our team at City of Hope is excited to be a part of the development of NeuroNova. Despite their potential, the first-generation oncolytic virus therapies given as free virus were not very effective — most likely due to rapid inactivation by the patient’s immune system. Our new platform uses stem cells like a ‘Trojan horse’ to shield the oncolytic viral particles from immune inactivation and deliver them to the tumor sites. This results in significantly more virus distributed at the tumor sites, inducing a greater self-amplifying anti-tumor response. This may also result in a secondary anti-tumor immune response,” said City of Hope’s Dr. Karen Aboody. “In addition to significant experience with this technology, City of Hope has a proven track record in GMP manufacturing of cell and gene therapy agents.”

About NeuroNova

The NeuroNova platform, NSC-CRAd-S-pk7, is an allogeneic, “off-the-shelf” therapy comprised of an immortalized Neural Stem Cell (NSC) line loaded with an engineered oncolytic adenovirus. Upon surgical resection of a tumor, NSC-CRAd-S-pk7 is injected into the walls of the resection cavity, resulting in viral infection and destruction of any remaining tumor cells. Calidi holds an exclusive worldwide licensing agreement for patents covering the NSC-CRAd-S-pk7 technology.

About Calidi Biotherapeutics

Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the effective delivery and potentiation of oncolytic viruses for targeted therapy against difficult-to-treat cancers. Calidi Biotherapeutics is advancing a potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications. Calidi’s off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses currently in development leading to enhanced efficacy and improved patient safety. Calidi Biotherapeutics is headquartered in La Jolla, California. For more information, please visit


Forward-Looking Statement

This press release contains forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” as well as similar terms, are forward-looking in nature. The forward-looking statements contained in this discussion are based on the Calidi’s current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Calidi will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Calidi’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: the occurrence of any event, change or other circumstances that could give rise to the termination of negotiations and any subsequent definitive agreements with respect to the business combination (the “Business Combination”) with Edoc Acquisition Corp. (“Edoc”); the outcome of any legal proceedings that may be instituted against Edoc, Calidi, the combined company or others following the announcement of the Business Combination, the private placement financing proposed to be consummated concurrently with the Business Combination (the “PIPE”), and any definitive agreements with respect thereto; the inability to complete the Business Combination due to the failure to obtain approval of the shareholders of Edoc, the possibility that due diligence completed following execution of the principal definitive transaction documents for the Business Combination and PIPE will not be satisfactorily concluded, the inability to complete the PIPE or other financing needed to complete the Business Combination, or to satisfy other conditions to closing; changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; the ability to meet stock exchange listing standards following the consummation of the Business Combination; the risk that the Business Combination disrupts current plans and operations of Calidi as a result of the announcement and consummation of the Business Combination; the ability to recognize the anticipated benefits of the Business Combination or to realize estimated pro forma results and underlying assumptions, including with respect to estimated shareholder redemptions; costs related to the Business Combination; changes in applicable laws or regulations; the evolution of the markets in which Calidi competes; the inability of Calidi to defend its intellectual property and satisfy regulatory requirements; the ability to implement business plans, forecasts, and other expectations after the completion of the proposed Business Combination, and identify and realize additional opportunities; the risk of downturns and a changing regulatory landscape in the highly competitive pharmaceutical industry; the impact of the COVID-19 pandemic on Calidi’s business; and other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Edoc’s preliminary prospectus dated May 25, 2022, in the Amended Registration Statement on Form S-4 filed with the Securities and Exchange Commission (“SEC”) on May 26, 2022.

Important Information About the Business Combination Transaction and Where to Find It

This press release relates to a proposed business combination between Edoc Acquisition Corp. a Cayman Islands exempted company, EDOC Merger Sub Inc., a Nevada corporation and Calidi Biotherapeutics, Inc., a Nevada corporation. A full description of the terms and conditions Agreement and Plan of Merger constituting the business combination is provided in the registration statement on Form S-4 filed with the U.S. Securities and Exchange Commission (SEC) by Edoc Acquisition Corp., that includes a prospectus with respect to the securities to be issued in connection with the merger, and information with respect to an extraordinary meeting of Edoc Acquisition Corp. shareholders to vote on the merger and related transactions. Edoc Acquisition Corp. and Calidi Biotherapeutics, Inc. urges its investors, shareholders and other interested persons to read the proxy statement and prospectus as well as other documents filed with the SEC because these documents will contain important information about Calidi Biotherapeutics, Inc., Edoc Acquisition Corp., and the business combination transaction. After the registration statement is declared effective, the definitive proxy statement and prospectus to be included in the registration statement will be distributed to shareholders of Edoc Acquisition Corp. and Calidi Biotherapeutics, Inc., as of a record date to be established for voting on the proposed merger and related transactions. Shareholders may obtain a copy of the Form S-4 registration statement, including the proxy statement and prospectus, and other documents filed with the SEC without charge, by directing a request to: Edoc Acquisition Corp. at 7612 Main Street Fishers, Suite 200, Victor, New York 14564. The preliminary and definitive proxy statement and prospectus included in the registration statement can also be obtained, without charge, at the SEC’s website (

Participation in the Solicitation

Edoc Acquisition Corp., Calidi Biotherapeutics, Inc., and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies or consents from Edoc Acquisition Corp. and Calidi Biotherapeutics, Inc. shareholders in connection with the proposed transaction. A list of the names of the directors and executive officers of Edoc Acquisition Corp. and Calidi Biotherapeutics, Inc. and information regarding their interests in the business combination transaction is contained in the proxy statement and prospectus. You may obtain free copies of these documents as described in the preceding paragraph.

No Offer or Solicitation

This press release will not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination. This press release will also not constitute an offer to sell or the solicitation of an offer to buy any securities of Calidi Biotherapeutics, Inc., nor will there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.