Latest news with #Gradient
Yahoo
3 days ago
- Business
- Yahoo
Gradient Denervation Technologies Announces Acceptance into FDA's Total Product Life Cycle Advisory Program for Development of its Pulmonary Artery Denervation System
PARIS, June 18, 2025 (GLOBE NEWSWIRE) -- Gradient Denervation Technologies announced today that it has been accepted into the Total Product Life Cycle Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel technology intended to treat patients with pulmonary hypertension and associated heart failure. The TAP Pilot acceptance follows the Company's recent announcement that the FDA granted Breakthrough Device Designation for the Gradient Denervation System. The FDA's Center for Devices and Radiological Health (CDRH) launched the TAP Pilot to help expedite patient access to safe and effective, innovative medical devices. To help accelerate development of Gradient's Denervation System, the TAP Pilot will allow the company to have early and frequent interactions with FDA as well as obtain strategic advice from providers, associations, payors and patient organizations. The Gradient Denervation System is a novel technology intended to treat patients with Group 2 pulmonary hypertension due to left-sided heart disease. Treatment is accomplished by ablating nerves around the pulmonary artery using therapeutic ultrasound energy in a minimally invasive, percutaneous procedure. The straightforward catheter platform was designed specifically for the pulmonary artery anatomy and leverages known interventional techniques. The treatment goal is to down-regulate the sympathetic activity in the pulmonary vascular tree to reduce vascular resistance and decrease pulmonary pressures. 'We're excited to be included in the TAP Pilot as the program will help streamline collaboration with FDA – from initiating our pivotal clinical study to accelerating access to this breakthrough therapy upon approval,' said Martin Grasse, Chief Executive Officer at Gradient Denervation Technologies. 'There are no approved drug or device therapies in the United States for this group of pulmonary hypertension patients, which reinforces the need to expedite access to new innovative therapies. We expect that guidance from TAP Pilot advisors will be immensely valuable in developing a targeted therapy intended to improve outcomes and quality of life for these underserved patients.' About Gradient Denervation TechnologiesGradient Denervation Technologies is a Paris-based medical device company developing a minimally invasive, ultrasound-based device for the treatment of pulmonary hypertension. Gradient leverages intellectual property developed at Stanford University. The Gradient Denervation System is for investigational use only and is not approved for commercial use. For more information, please visit: CONTACT: Media Contact contact@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
3 days ago
- Business
- Yahoo
Gradient Denervation Technologies Announces Acceptance into FDA's Total Product Life Cycle Advisory Program for Development of its Pulmonary Artery Denervation System
PARIS, June 18, 2025 (GLOBE NEWSWIRE) -- Gradient Denervation Technologies announced today that it has been accepted into the Total Product Life Cycle Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel technology intended to treat patients with pulmonary hypertension and associated heart failure. The TAP Pilot acceptance follows the Company's recent announcement that the FDA granted Breakthrough Device Designation for the Gradient Denervation System. The FDA's Center for Devices and Radiological Health (CDRH) launched the TAP Pilot to help expedite patient access to safe and effective, innovative medical devices. To help accelerate development of Gradient's Denervation System, the TAP Pilot will allow the company to have early and frequent interactions with FDA as well as obtain strategic advice from providers, associations, payors and patient organizations. The Gradient Denervation System is a novel technology intended to treat patients with Group 2 pulmonary hypertension due to left-sided heart disease. Treatment is accomplished by ablating nerves around the pulmonary artery using therapeutic ultrasound energy in a minimally invasive, percutaneous procedure. The straightforward catheter platform was designed specifically for the pulmonary artery anatomy and leverages known interventional techniques. The treatment goal is to down-regulate the sympathetic activity in the pulmonary vascular tree to reduce vascular resistance and decrease pulmonary pressures. 'We're excited to be included in the TAP Pilot as the program will help streamline collaboration with FDA – from initiating our pivotal clinical study to accelerating access to this breakthrough therapy upon approval,' said Martin Grasse, Chief Executive Officer at Gradient Denervation Technologies. 'There are no approved drug or device therapies in the United States for this group of pulmonary hypertension patients, which reinforces the need to expedite access to new innovative therapies. We expect that guidance from TAP Pilot advisors will be immensely valuable in developing a targeted therapy intended to improve outcomes and quality of life for these underserved patients.' About Gradient Denervation TechnologiesGradient Denervation Technologies is a Paris-based medical device company developing a minimally invasive, ultrasound-based device for the treatment of pulmonary hypertension. Gradient leverages intellectual property developed at Stanford University. The Gradient Denervation System is for investigational use only and is not approved for commercial use. For more information, please visit: CONTACT: Media Contact contact@
Yahoo
09-06-2025
- Business
- Yahoo
Gradient Mortgage Capital Launches to Empower Mortgage Professionals with Premier Small Balance Commercial and DSCR Mortgage Lending Solutions
An Affiliate of Saluda Grade, Gradient Offers Tailored Wholesale Loan Solutions for 1–4-Unit Investor Residential and Small Balance Commercial Properties FORT LAUDERDALE, Fla., June 9, 2025 /PRNewswire/ -- Gradient Mortgage Capital, a newly launched wholesale mortgage banking platform, is excited to announce its official market entry, offering innovative financing solutions to mortgage bankers and brokers nationwide. Specializing in Debt Service Coverage Ratio (DSCR) loans for 1-4-unit investor residential properties and Small Balance Commercial Real Estate (SBCRE) loans for a wide variety of property types, Gradient is committed to providing fast, flexible, and reliable lending solutions that help clients scale with confidence. As an affiliate of Saluda Grade, an alternative investment firm specializing in asset-based credit, Gradient benefits from the backing of a firm focused on emerging asset classes and innovative capital solutions. This affiliation provides Gradient with the financial resources to offer mortgage bankers and brokers a competitive edge in a rapidly evolving marketplace. Gradient Mortgage Capital understands that every deal is unique, which is why their loan solutions are designed to help mortgage intermediaries assist entrepreneurial real estate investors at every stage of their journey. Whether their borrower is acquiring their first investment property or refinancing an expanding portfolio, Gradient's streamlined process and commonsense underwriting provide speed and certainty of close, ensuring borrowers get the financing they need when they need it most. "Our mission is rooted in delivering exceptional value through creativity, consistency, and commitment," said Jeremy Irwin, CEO of Gradient Mortgage Capital. "We're here to support our partners with a deep focus on the customer experience, earning your trust by making every interaction reliable, transparent, and frictionless. With Gradient, it's not just about funding transactions; it's about building lasting relationships and helping our partners grow." By combining capital, creativity, and consistency, Gradient offers more than just loans—it builds momentum. With a focus on collaboration, exceptional service, and a commitment to getting deals done right, Gradient provides mortgage professionals with the tools they need to succeed in a competitive landscape. Gradient Mortgage Capital's tagline, "Where Opportunity Meets Altitude," reflects the company's vision to elevate its clients by delivering tailored lending solutions that empower growth, drive success, and unlock new opportunities. For more information about Gradient Mortgage Capital, its DSCR and Small Balance Commercial loan programs, or to become an approved partner, visit About Gradient Mortgage CapitalGradient Mortgage Capital is a wholesale mortgage banking platform and affiliate of Saluda Grade, specializing in DSCR loans for 1–4-unit investor residential properties and Small Balance Commercial Real Estate (SBCRE) loans. With a focus on speed, flexibility, and exceptional service, Gradient empowers mortgage brokers and bankers to deliver tailored financing solutions that help real estate investors scale smarter and more efficiently. About Saluda GradeSaluda Grade is an alternative investment firm specializing in asset-based finance, with a focus on residential real estate. Founded in 2019, the firm has an AUM of $2.5 billion* as of June 1, 2025, and is headquartered in New York City. Disclaimer: This press release is for informational purposes only and does not constitute an offer to sell, a solicitation of an offer to buy, or a recommendation of any securities or investment products. All investing involves risk, including the potential loss of principal.* Saluda Grade acquired Hillcrest Finance, LLC on June 1, 2025. Integration of business operations is ongoing; at this time, the regulatory assets under management (AUM) of the two entities remains as an investment adviser does not imply a certain level of skill or training. View original content to download multimedia: SOURCE Gradient Mortgage Capital, LLC Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-06-2025
- Business
- Yahoo
Infisical raises $16 million Series A led by Elad Gil to safeguard secrets
Vlad Matsiiako is in the business of secrets. 'If secrets aren't there, then it's just not possible for software to run,' said Matsiiako, CEO and cofounder of Infisical. 'Databases can't connect to each other. Developers can't use any resources. AI agents can't integrate with the whole ecosystem. Basically, secrets are the glue that connects everything. And if they're not there, there's no way for organizations to secure systems. They can't really run things, it's not really operational. The majority of vulnerabilities these days are still related to secrets and identities.' Secrets refer to any and all sensitive information that protects and authorizes access to systems—think: passwords, encryption keys, API keys, and more. And Infisical is a secrets management platform for developers and companies, offering the tech to securely store, change, and retrieve vital credentials. Founded in 2022 by Matsiiako with Tony Dang and Maidul Islam, Infisical's now raised a $16 million Series A, led by Elad Gil. Y Combinator, Gradient, and Dynamic Fund participated, plus angels like Datadog CEO Olivier Pomel, Samsara CEO, and Valor CEO Antonio Gracias. Infisical's current customers include Hugging Face, Lucid, and LG. At first, Matsiiako expected he'd be mostly selling to tech companies, but found that non-tech-centric sectors were drawn to the product—banks, pharmaceutical companies, government, manufacturers, and mining organizations with extensive software infrastructure requiring secret management. Infisical has been expanding its product suite over the last year, to things like certificate management and SSH key management, and more. 'We're working with AI agents right now,' said Matsiiako, who's originally from Ukraine. 'Right now, the biggest growth area is all of these AI workloads, agents and applications—Cursor and so on. They write so much code, but they can only write code as quickly as they get access to different databases and different resources.' The secrets business is big—HashiCorp, an incumbent, sold to IBM for $6.4 billion in a deal finalized in February. And most reports show secrets management to be a growing market, worth well into the billions by 2030. In Infisical's case, the company said that it's cash flow positive and has grown revenue by 20 times over the last year. (The startup declined to disclose revenue.) 'As an investor and founder, I really look for things where there's a strong market pull,' said investor Elad Gil. 'You can be Sisyphus, rolling the boulder uphill all day. Or you can find something where the boulder's rolling downhill a little on its own—or at least, where the founder is pushing really hard, but gravity is helping. So, you're looking for the startup version of positive gravity…You want that market pull because without it, you're doing everything. And Infisical had that really clear product-market fit, that pull from customers who really wanted what they were building.' There were, of course, moments when the Infisical team did have to push boulders. Matsiiako, Dang, and Islam met as students at Cornell and cycled through other startup ideas—a VR marketplace, for one—before landing on secrets. They faced a time crunch in incorporating the company: They'd both just gotten into YC and as international students, they had visas to think about. The name 'Infisical' was born from that urgency, a blend of 'infinity' and 'physical'—meant to evoke something both expansive and tangible. And though the company has made fast progress—Infisical's software has been downloaded more than 40 million times globally in the past year—the early days were tough. When they entered Y Combinator's Winter 2023 batch, Infisical was a closed-source SaaS tool for managing developer secrets. The product worked technically, but the team struggled to gain traction and earn users' trust. A candid talk with YC group partner and managing director Dalton Caldwell changed everything. 'Obviously, there were [open source] YC success stories, like GitLab or Docker,' said Matsiiako. 'We were talking to Dalton, who'd worked with GitLab and others. We were like: We're hearing we need to open source this, but what if we lose our IP rights? And Dalton said: 'Guys, this thing is not working. What IP rights are you talking about? Just do it.'' The following week, the Infisical team open sourced the tech. It went viral, especially via Reddit. They woke up the next morning to users telling them that developer newsletters were featuring the project, a deluge of feature requests, and their first international contributor. 'Now, people could actually see the code,' said Matsiiako. 'They could see how the encryption works. And that was where trust came from.' As it turns out, secrets can only be shared with trust. IPO wrap…On Thursday, Circle went public on the NYSE, raising $1.05 billion. Today, Omada Health is slated to go public on the Nasdaq, targeting a $1 billion valuation. And not an IPO, but a 'wow': Anduril is now valued at $30.5 billion. Read my colleague Jessica Mathews' story here. See you Monday, Allie GarfinkleX: @agarfinksEmail: a deal for the Term Sheet newsletter here. Nina Ajemian curated the deals section of today's newsletter. Subscribe here. This story was originally featured on Sign in to access your portfolio
Yahoo
19-05-2025
- Health
- Yahoo
Gradient Denervation Technologies Announces FDA Breakthrough Designation for Pulmonary Artery Denervation System
PARIS, May 19, 2025 (GLOBE NEWSWIRE) -- Gradient Denervation Technologies announced today the company's pulmonary denervation system has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This program creates an expedited review pathway for devices that have the potential to provide more effective treatment for life-threatening or debilitating conditions and meet FDA's rigorous standards for safety and efficacy. The Gradient Denervation System is a novel technology intended to treat patients with pulmonary hypertension and associated heart failure. Treatment is accomplished by ablating nerves around the pulmonary artery using therapeutic ultrasound energy in a minimally invasive, percutaneous procedure. The straightforward catheter platform was designed specifically for the pulmonary artery anatomy and leverages known interventional techniques. The treatment goal is to down-regulate the sympathetic activity in the pulmonary vascular tree to reduce vascular resistance and decrease pulmonary pressures. The PreVail-PH2 Early Feasibility Study is enrolling patients with pulmonary hypertension due to left-sided heart disease, classified by the World Health Organization (WHO) as Group 2 Pulmonary Hypertension. As many as two-thirds of heart failure patients around the world have elevated pulmonary vascular resistance, which is shown to lead to an increased risk of mortality and hospitalization. There are no approved drug or device therapies in the United States for this group of pulmonary hypertension patients. 'We are thrilled with this positive feedback from FDA. The granting of Breakthrough Device Designation marks another important milestone for our pulmonary denervation clinical development program,' said Martin Grasse, Chief Executive Officer of Gradient. 'We remain focused on completion of our early feasibility study as a crucial first step toward developing a targeted treatment option with the potential to improve outcomes and quality of life for these underserved patients.' About Gradient Denervation TechnologiesGradient Denervation Technologies is a Paris-based medical device company developing a minimally invasive, ultrasound-based device for the treatment of pulmonary hypertension. Gradient leverages intellectual property developed at Stanford University. The Gradient Denervation System is for investigational use only and is not approved for commercial use. For more information, please visit: CONTACT: Media Contact info@ in to access your portfolio
