| Over a week ago | ||||
BioCardia announced that… BioCardia announced that the next Data Safety Monitoring Board, DSMB, meeting for the CardiAMP Cell Therapy Trial for Heart Failure is scheduled to take place on July 12th. The Company expects the FDA's response to its adaptive statistical analysis plan supplement early to mid-June and anticipates approval of the plan and completion of all tasks to implement the plan, including all data monitoring, in advance of the DSMB meeting. | ||||
Reports Q1 revenue $64K,… Reports Q1 revenue $64K, consensus $340K. "Our autologous and allogeneic cell therapy programs are advancing in the clinic, with three enabled by our Helix cardiac biotherapeutic delivery system and a fourth using intravenous delivery," said Peter Altman, Ph.D., President, and CEO. "This past quarter our lead CardiAMP cell therapy for heart failure program had positive two-year data, additional patients enrolled and new centers consenting their first patients. For this program, we have had productive interactions with the FDA towards implementing an adaptive statistical analysis plan and have been preparing for submission towards approval in Japan. We are also engaged in discussions for six out licensing and product distribution opportunities with an intent to close two in 2023, in parallel to delivering our product milestones." | ||||
BioCardia announces that… BioCardia announces that the United States Patent Office has granted Patent Number 11,642,377: titled, " Bone Marrow Derived Neurokinin-1 Receptor Positive Mesenchymal Stem Cells for Therapeutic Applications", with a patent term that will expire in 2039. The patent specification details methods for selecting and expanding NK1R+ Mesenchymal Stem Cells and their use to treat a number of diseases. The first allowed claim protects using these cells to treat cardiovascular disease, pain, rheumatoid arthritis, diabetes, stroke, asthma, pulmonary fibrosis, and aging. There are seventeen additional claims allowed in this patent issuance. | ||||
| Over a month ago | ||||
BioCardia announced the… BioCardia announced the issuance of two patent grants related to enabling technologies for delivery of its investigational autologous and allogeneic cell therapies. The United States Patent Office, USPTO, issued BioCardia Patent Number 11,716,859, entitled "Multi-Directional Steerable Catheter," with a patent term that will expire in 2035. The patent claims a fundamental design for steerable introducer sheaths, such as those used for BioCardia's autologous and allogeneic cell therapy procedures, and for transseptal procedures for the treatment of cardiac arrhythmias. The design enables the tensioning elements in the catheter to rotate around the catheter shaft, allowing consistent catheter performance in any direction. This design is intended to enable smooth navigation and prevent "whip," when a catheter in the heart suddenly jumps from one orientation to another due to the build-up of mechanical forces in the device. This patented design is incorporated in the Company's FDA-cleared Morph DNA product, a 5 French sheath equivalent, and in the Company's FDA-cleared Avance product, an 8.5 French introducer sheath indicated for transseptal procedures. The Indian Patent Office granted the Company Patent Number 424579, entitled "Steerable Endoluminal Devices and Methods for Use," with a patent term that will expire in late 2031. The patent claims a fundamental design for steerable introducer sheaths. The design is for a coil with a braid disposed coaxially about the coil, all embedded within the wall of an introducer sheath. The coil enables a robust, kink-resistant design with enhanced column support, while the braid in the catheter shaft provides for excellent torque transmission. This patent design feature has demonstrated excellent performance in the Company's Morph Access Pro product family and has been used to treat approximately 10,000 patients to-date, ranging from a two-year-old girl to a 90-year-old man. | ||||
Net cash used in… Net cash used in operations was approximately $10.6 million in 2022, compared to $10.4 million in 2021. The Company ended the year with cash and cash equivalents totaling $7.4 million, providing runway into the third quarter of 2023. | ||||
Reports 2022 revenue… Reports 2022 revenue $1.35M vs. $1.02M last year. "I am tremendously proud of the BioCardia team and its clinical partners for the regulatory, reimbursement and clinical progress we have made over the last year," said BioCardia CEO Peter Altman, Ph.D. "We are now advancing four novel autologous and allogeneic cell therapies in clinical studies, each of which is delivered locally to the heart or the lungs, where they are intended to stimulate natural reparative processes and reduce inflammation. This year holds the potential for catalysts that could dramatically improve our prospects, timetable, and attractiveness as a business. We are excited about what the future holds and are grateful for the opportunity in front of us to create an entirely new class of heart failure treatments with the potential to transform cardiovascular and pulmonary care." | ||||
BioCardia announces that… BioCardia announces that detailed echocardiography data from the roll-in cohort of the Phase III CardiAMP Cell Therapy Heart Failure Trial is being presented at the American College of Cardiology annual meeting by Peter Johnston, M.D., Assistant Professor of Medicine and Site Principal Investigator at Johns Hopkins University. Results from the 10-patient roll-in cohort of the clinical trial showed that myocardial wall motion in the 16 regions of the heart was more often characterized as normal after the study treatment at one year follow-up, and at two-year follow-up, as measured by the blinded echocardiography core lab at Yale University: In this series, only 13 percent of heart segments in these patients were contracting normally before treatment; at one year, 25 percent were contracting normally and at two years, 29 percent were contracting normally- indicating a more than doubling of the number of heart segments characterized as having normal function post-procedure. In completely non-functioning heart segments, 17 of 56, or 30 percent, of those heart segments resumed wall motion by two years. The overall wall motion score index for all 16 segments in the heart was improved, decreasing from 2.4 at baseline to 2.0 at one year to 1.9 at two years. As a result of the restoration of myocardial wall motion, patients experienced an improvement in median left ventricular ejection fraction, which increased from 27 percent at baseline to 34 percent at one year, to 37 percent at two years. | ||||
| Over a quarter ago | ||||
BioCardia and… BioCardia and CellProthera, a private developer of cell-based therapies to repair ischemic tissues, announce an amendment to their Clinical Research Supply and Support Agreement. The amendment extends the long-term partnership between both organizations. The agreement relates to CellProthera's use of BioCardia's Helix transendocardial biotherapeutic delivery system for its ongoing Phase I/IIb EXCELLENT study of its lead product candidate ProtheraCytes. CellProthera has developed ProtheraCytes as a one shot minimally invasive autologous ATMP cell therapy to improve the quality of life of post-Acute Myocardial Infarction patients who have no therapeutic solution to restore the heart's function, and to reduce ongoing hospitalizations and invasive medical treatments such as heart transplants. CellProthera and BioCardia have extended the agreement to complete the ongoing Phase I/IIb EXCELLENT study. The agreement incorporates the intention for both organizations to work together regarding CellProthera's next clinical study, potential early access commercialization, which could begin in 2024, and future full commercialization programs. | ||||
BioCardia issued a letter… BioCardia issued a letter to shareholders, which read in part, "BioCardia is now advancing four novel cell therapies, with three focused on heart disease, a leading cause of death and reduced quality of life globally. The Phase III trial of our lead therapy - CardiAMP autologous cell therapy for ischemic heart failure - continues to enroll in the U.S. and Canada, and data published to-date is showing improved functional capacity and quality of life in treated patients. Most encouraging is the combined mortality rate across the Phase I, II and III trial data available, which is less than3% per year, exceptional in a landscape where leading pharmaceutical solutions are showing mortality that is 3x higher. The FDA has supported this promise by granting Breakthrough Device Designation to CardiAMP cell therapy in this indication. We have embarked on a Phase III trial of CardiAMP autologous cell therapy in a second indication addressing chronic myocardial ischemia, and this year received IND approval from the FDA to study two allogeneic product candidates, both leveraging Neurokinin-1 receptor positive allogeneic mesenchymal stem cells - BCDA-03 for ischemic heart failure and BCDA-04 for acute respiratory distress syndrome. The NK1R+ cells are particularly interesting as NK1 is the primary receptor for Substance P, an important neuropeptide mediator of inflammation which plays a central role in both heart failure and regenerative processes following myocardial injury...An adaptive SAP design is well underway using a Bayesian approach and we anticipate looking at the operating characteristics for the design in early January with an FDA "sprint discussion" afforded under the breakthrough designation to follow. In parallel, we anticipate all data that contributes to the primary efficacy endpoint in the study submission to have been monitored by our very capable clinical research staff verifying all clinical data required for interpretation. While we expect this will all be in place for a DSMB review in Q2 2023, there are also no guarantees we will be able to implement such a plan or that implementation of such a plan will result in an early end to the clinical trial for efficacy at of the future DSMB review...We expect 2022 work on the regulatory and reimbursement fronts, activation of the trial in Canada, and enhanced patient education efforts to have a positive impact on enrollment in 2023. We also intend to publish and present new data from the CardiAMP HF Trial designed to further influence referrals to the trial among heart failure specialists. To this point, we have seen some reluctance among these specialists concerned about losing control of patients to physicians in the trial, expressing the aforementioned skepticism about cell therapy, and feeling that the new heart failure drugs available will adequately serve their patients...In 2023, we intend to submit for regulatory approval of CardiAMP cell therapy in Japan. We plan to prioritize pursuit of a petition for a special designation as a highly needed medical therapy from a leading Japanese clinical society to the Ministry of Health Labor and Welfare to support enhanced reimbursement and regulatory approval. Should the special designation not be granted, we will pursue regulatory approval through a traditional pathway...On the heels of our 2022 deal with BlueRock Therapeutics to provide our Helix delivery system for their therapeutic development efforts, we are discussing partnerships with leading biopharmaceutical firms where BioCardia may benefit from licensing fees and milestones during development, as well as a percentage of sales once those therapies enabled by our delivery products are commercial. In parallel to our efforts to achieve regulatory approval in Japan, we are in discussions with potential distribution partners in Japan which, if finalized, could lead to commercial revenue...Now that we have both INDs approved by FDA and clinical-grade cells manufactured in our facility, the next milestones for our allogeneic NK1R+ mesenchymal stem cell indications of heart failure and acute respiratory distress involve treating the first patients in these studies. For the acute respiratory distress indication, we are actively completing the clinical site start-up phase of aligning on patient informed consent, clinical study agreement, and budget which we anticipate completing for at least one site in the weeks ahead. Even as we make progress on these new programs, our priority is our BCDA-01 CardiAMP cell therapy program based on the positive data we are seeing and the Breakthrough designation that has potential to accelerate our regulatory and commercial efforts." | ||||
