SoniVie | June 20, 2022
SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound System to treat a variety of hypertensive disorders, announced that on May 5th 2022 the U.S. Food and Drug Administration granted IDE approval for its "REDUCED1" Pilot study to treat Resistant Hypertension Patients with Renal Artery Denervation using TIVUS™, its innovative Ultra-Sound Ablation System.
Resistant hypertension is defined as blood pressure higher than 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses, one of which must be a diuretic. Millions of people world-wide suffer from resistant hypertension which substantially increases the risk of heart attack, stroke and kidney failure.
"We are very pleased that FDA has approved the REDUCED1 study. Sites initiation has started, and many clinical teams have responded very favourably about participating to the study. There is a significant number of patients that may benefit from our technology and we are genuinely happy for this important step towards the introduction of TIVUS™ in the US. There is a lack of effective therapeutic solutions for patients suffering from resistant hypertension, and physicians are looking forward to a safe, effective and easy to use device treatment,"
Christian Spaulding, CMO, SoniVie Ltd
"This is a significant US Regulatory milestone for SoniVie, starting the feasibility study using the Ultra-Sound ablation platform in the US for the Renal Denervation indication. This is a major step and priority in the company's history," says Tomaso Zambelli, CEO, SoniVie LTD.
The REDUCED1 study will further expand the Company's clinical experience based on two clinical trials in Renal Denervation performed using the earlier generation of the TIVUS™.
Renal Denervation with TIVUS™ is a minimally invasive procedure that uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal artery. This causes a reduction in the nerve activity, which may decrease blood pressure. This procedure is designed for patients who suffer from resistant hypertension.
SoniVie is a medical device company developing the TIVUS™, the only Ultra-Sound Denervation platform with active development programs in three therapeutic areas: pulmonary artery denervation for pulmonary hypertension, renal artery denervation for resistant hypertension, and lung denervation for chronic obstructive pulmonary disease with chronic bronchitis. These diseases affect millions of patients in the United States and Europe.
Titan Pharmaceuticals, Inc. | February 03, 2022
Titan Pharmaceuticals, Inc. announced that it has entered into a securities purchase agreement with a single institutional investor to purchase 3,374,242 shares of its common stock (or pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, Titan has also agreed to issue and sell to the investor 1,289,796 pre-funded warrants, at the same purchase price as in the registered direct offering. In addition, the Company has agreed to issue to the investor in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,664,038 shares of common stock. The combined offering price of each share or pre-funded warrant and each warrant will be $1.18. The warrants will be immediately exercisable, will expire on the five year and six month anniversary of the issuance date and will have an exercise price of $1.14 per share.
The aggregate gross proceeds to the Company of both offerings is expected to be approximately $5.5 million. The offerings are expected to close on or about February 4, 2022, subject to the satisfaction of customary closing conditions.
Maxim Group LLC is acting as the exclusive placement agent in connection with the offerings.
The shares of common stock in the registered direct offering are being offered pursuant to a shelf registration statement on Form S-3 which was declared effective by the United States Securities and Exchange Commission ("SEC") on April 24, 2019. The pre-funded warrants and warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws.
This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock issued in the registered direct offering will be filed by Titan with the SEC.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. Ultimate validation of the ProNeura® delivery system has been exemplified by approval of Probuphine in the US (FDA), EU and Canada.
MEDITECH | June 15, 2022
MEDITECH announced that it has received the 2021 Google Cloud Industry Solution Partner of the Year award for Healthcare.
MEDITECH was recognized for its achievements in the Google Cloud ecosystem, helping joint customers to develop systems that complement their EHR with scalable, secure data storage and access.
Built to harness Google Cloud for patient data storage and access, provider mobility, and organizational efficiency, MEDITECH Expanse encompasses a growing suite of solutions that deliver innovative, cost-effective healthcare technology.
The company also deployed MEDITECH Cloud Platform, a set of new applications including Expanse Patient Connect, Expanse Now, Virtual Care, and High Availability SnapShot that provide providers and patients with a better, more mobile healthcare experience.
“We’re proud to recognize MEDITECH as our Industry Partner of the Year for Healthcare, based on their deep knowledge and evident experience in helping customers across the healthcare industry succeed,” said Bronwyn Hastings, VP of Global ISV Partnerships and Channels, Google Cloud. “MEDITECH has demonstrated strong technical and service capabilities over this past year, and we look forward to expanding our work together to help healthcare organizations digitally transform their businesses.”
Most recently, MEDITECH released Expanse Ambulatory for independent physician practices, representing its entry into a new segment of the healthcare market and leveraging Google Cloud to deliver an intuitive cloud-based practice management solution to more organizations.
MEDITECH maintained a strong pace of new customer signings and solution deployments that further expanded its reach and bolstered the company’s reputation as a proven partner for health systems of all sizes.
Propelled by the deployment of new solutions such as Ambulatory and impressive sales of the cloud-based MEDITECH as a Service (MaaS) deployment model, MEDITECH secured the second-largest market share growth in the EHR space in 2021.
The company’s continued market growth in the large hospital segment again earned plaudits from the global healthcare research firm KLAS, which ranked MEDITECH Expanse #1 in Acute Care EMR (Community Hospital), Patient Accounting & Patient Management, and Home Health EHR.
“Our embrace of Google Cloud-powered solutions is a further evolution of MEDITECH’s stance that the time for incremental change is over. We have set out to redefine what an EHR can be,” said MEDITECH Vice President Scott Radner. “We are honored to be recognized by Google Cloud for creating healthcare solutions that ensure faster development, lower costs, and better health outcomes. Our goal is to help healthcare organizations realize tomorrow’s possibilities, today.”
MEDITECH empowers healthcare organizations around the world to expand their vision of what’s possible with Expanse, the intuitive EHR setting new standards for usability, efficiency, and personalization. Our agile innovation is advancing the productivity of busy clinicians in 23 countries, driving positive clinical outcomes and patient experiences. MEDITECH solutions span every care setting, from acute centers and ambulatory practices, to home health and hospice, long-term care and behavioral health facilities, outpatient services, patients’ homes and beyond. Expand your possibilities.
Arrowhead Pharmaceuticals | December 21, 2021
Arrowhead Pharmaceuticals, Inc. announced that it has completed a transaction to purchase 13 acres of land in the Verona Technology Park in Verona, WI, which is planned to be the site of an approximately 140,000 square foot drug manufacturing facility and an approximately 115,000 square foot laboratory and office facility to support process development and analytical activities. Arrowhead intends to invest between $200 million and $250 million into the buildout of the facilities. The Company expects that the new facilities will result in the creation of approximately 250 new jobs in the local area. Construction is scheduled to begin in the first quarter of 2022. Arrowhead will continue to operate additional research and development facilities in Madison, WI, and San Diego, CA.
“For more than a decade, Arrowhead has been a dedicated member of the biotech community in the greater Madison, Wisconsin, area. We have built strong local relationships and are pleased to continue our growth with the new Arrowhead campus that will include a new GMP manufacturing facility and associated lab and office facility. This investment reaffirms our commitment to the Wisconsin biotech ecosystem, and we would like to thank the local agencies, who have been a pleasure to work with. Arrowhead’s pipeline of what we believe are industry leading investigational RNAi medicines continues to expand rapidly. The new Arrowhead campus will allow us to support our growing pipeline and positions us well to advance the manufacturing process, including at commercial scale, of our TRiM™-enabled drug candidates. We view this as a strong competitive advantage as we approach potential commercialization of our rapidly progressing clinical candidates.”
Christopher Anzalone, Ph.D., Arrowhead’s president and CEO
Major project team members include Eppstein Uhen Architects, DPS Group, D’Onofrio Kottke & Associates, Smocke & Associates, Cresa Madison, and Vogel Brothers Building Company.
John Chapman, Vice President and Design Principal at EUA, said, “We are privileged to be collaborating again with Arrowhead on an inventive building design which will enable their employees to treat some of the most challenging diseases.”
Completion of the lab and office space is anticipated in the first quarter of 2023 and completion of the manufacturing facility is expected in the fourth quarter of 2023.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.