Symple Surgical Inc, Renal Sympathetic Denervation, Medical Microwave Ablation Technology and Devices

We are Symple Surgical

Symple Surgical is an exciting start-up Medical Device company focused on developing novel therapeutic technologies through controlled Microwave Ablation. Our technologies are thoughtfully designed to be familiar and easy to use by the operator while providing superior control, feedback, and safety for the patient.

Symple Surgical’s first product offering is the DirectAblate Renal Denervation System™. Through the ground-breaking therapy of directed renal sympathetic denervation (dRDN), we are focused on helping hundreds of millions of patients worldwide living with chronic hypertension (High Blood Pressure) through. DirectAblate Renal Denervation System™ delivers microwave thermal energy directly to the precise location of overactive sympathetic nerves while minimizing thermal exposure to non-targeted tissue. Renal Denervation has proven to be a safe and effective way to treat uncontrolled Hypertension in a short one-time minimally invasive vascular procedure.

Due to the unique characteristics of Microwave Energy, wide-ranging applications for this technology cross-over into the fields of Interventional Cardiology, Electrophysiology, Nephrology, Pulmonology and Vascular Intervention. Symple Surgical has established an exciting pipeline of products targeting growing markets in minimally invasive medicine.

Symple Surgical, Inc. is a privately-held company with engineering and product development offices in Northern California and Flagstaff, AZ. We are comprised of a highly experienced team of Medical Device professionals with global experience covering research and development (R&D) through product commercialization. We are backed by a world class Scientific Advisory Board of clinicians and researches dedicated to developing therapeutic microwave technology for superior treatment of life-threatening chronic conditions

Our Technology

Circumferential Ablation | Preserved Arterial Surface | Simple PTA Procedure

The Symple Surgical DirectAblate Renal Denervation System™ catheter is a low profile over-the-wire, semi-compliant nylon balloon system. The entire system is engineered to provide PTA like catheter elegance and superb ease of use within the procedural challenges of renal denervation. Initial product offering utilizes a 7-French over-the-wire single use catheter design, .014 guidewire compatibility. The device is available in 5mm, 6mm, and 7mm diameter sizes with a single length of 18mm. At the core of the DirectAblate Renal Denervation System™ is a proprietary self-centering internally integrated microwave antenna, real-time surface temperature monitoring, and active arterial wall cooling for safety. A 100 Watt / 2.45 GHz microwave generator with integrated control system provides precise control and data acquisition. DirectAblate Renal Denervation System™ has superior catheter and energy delivery technology that effectively delivers a single 90 second circumferential non-contact ablation per renal artery.

Validated Thermal Simulation
Using thermal simulation and laboratory testing, Symple Surgical optimizes the DirectAblate Renal Denervation System™ and delivers therapeutic microwave energy to Sympathetic Nerves.

Through comprehensive thermal simulation and laboratory testing, Symple Surgical has optimized the DirectAblate Renal Denervation System™ to deliver therapeutic microwave energy to the site of the Sympathetic Nerves. Figure 1 shows Computer Generated Thermal Simulation data of the DirectAblate Renal Denervation System™. Figure 2 is histological sample of an in vivo study performed with the DirectAblate Renal Denervation System™. The treatment zone is nearly identical in size and shape to the computer based modeling as identified with NBT viability staining (blue/purple coloring is preserved tissue; translucent/white is treated tissue; rings are 1mm spacing).

directed Renal Denervation (dRDN)

The Symple Surgical microwave device is demonstrated within a protein albumin gel highlighting the “doughnut-shape” circumferential ablation zone created. While penetrating 6mm deep in to the protein gel, the test demonstrates the thermal protection of the vessel wall and the 1mm ring of the medial layer. Past the 6mm ablation zone there is a substantial drop-off in temperature, thereby limiting damage to the non-target perivascular structures.

Our Team

Our Vision

To assemble a talented team focused on improving patient health through the development of novel Microwave Therapies while enriching our Employees’ lives. Foster a culture of innovation resulting in rapid and concise decision making with the ultimate goal of inventing and commercializing superior products for the treatment of chronic conditions.

Management Team

Two proven medical device entrepreneurs, Daniel J. Kasprzyk and Randy Preston, founded Symple Surgical in 2012.

Mr. Kasprzyk has over 25 years’ experience in the medical device industry as an executive in startup and multinational business platform companies and holds numerous patents in the device and medical equipment space. He has held Senior Management and Product Development positions in companies such as Medex Inc., Advanced Cardiovascular Systems (Guidant Corporation), Spectranetics Inc., B. Braun Medical, and W.L Gore & Associates. He has co-founded successful medical startup ventures, Vascular Solutions and Machine Solutions. He received his B.S.E. in Bioengineering from Arizona State University in 1985.

Mr. Preston has over 12 years’ experience in the medical device industry in a variety of business development, project management, and operational positions. Most recently, he spearheaded the successful start-up of Machine Solutions, GmbH in Munich, Germany and spent three years building a European operations team as a subsidiary of Machine Solutions Inc before successfully overseeing the transition to an EU based operational team. His experience in the minimally-invasive field covers a wide range of products including DES, Structural Heart Devices, and Peripheral Intervention devices. He received his B.S. in Mechanical Engineering from Cal Poly San Louis Obispo in 2003.

SSI Core
With a stronge team of Scientific clinicians and researches, SSI is dedicated to developing therapeutic microwave technology for the treatment of life-threatening chronic conditions, we are Symple Surgical Inc. Symple Surgical has a dedicated team of experienced Medical Device professionals and world-class contract suppliers committed to developing and producing the most advanced technology for the market. We utilize expert consultants in specialized fields and maintain a core team exclusively focused to the development and production of our proprietary technology. As an early-stage start-up we are committed to running a lean operation.
Resources
Hypertension and resistant Hypertension
In the United States today, 80 million adults are affected by chronic high blood pressure, known as Hypertension, and nearly 1 billion people worldwide. Chronic high blood pressure is linked to heart disease, stroke, kidney disease, and diabetes. The consequences of high blood pressure to domestic and global health are staggering:
  • Heart disease caused by hypertension, is the leading causes of death in U.S and globally
  • Stroke is the fifth leading causes of death domestically and worldwide
  • Hypertension accelerates loss of kidney function in over 500m people worldwide and 26m Americans
  • The global incidence of Hypertension among adults is expected to increase 60% by 2025
More severe resistant Hypertension is defined as blood pressure above optimal range despite the use of maximum tolerated doses of at least three antihypertensive medications including a diuretic. Resistant hypertension prevalence is approximately 5-8% of total adult population. Complications from pharmaceutical therapies create the biggest impact to quality of life in patients with resistant Hypertension.
The Sympathetic Nervous System
The Sympathetic Nervous System from Symple Surgical Inc.
Why Microwave
Microwave vs. RF Heating
Microwave vs. RF Heating from Symple Surgical Inc. RF Ablation has limited capability compared to Microwave Ablation. Advantages of Microwave Ablation include:
  • Faster Heating
  • Larger Heating Zone
  • More Uniform Heating Zone
  • Less dependent on Tissue Properties
  • No grounding pad or 2nd pole necessary
  • Tissue contact is not necessary
  • Independent of wall pressure
The heating zone is controlled by several factors including: Power, Frequency, Antenna Design, and the material properties in the near-field of the antenna.
Patient Resources
Hypertension, more commonly known as High Blood Pressure, is a critical health condition that if left untreated can have serious adverse consequences. If you or someone you know is suffering from High Blood Pressure you should seek medical attention. Additional information can be found from the following Health Agencies:
Beyond Hypertension
In small pilot studies, Sympathetic Denervation has shown promise in being a beneficial therapy for several life-threatening conditions including:
Information Center
Follow SSI
Careers

Symple Surgical is a dynamic start-up medical device company working on ground-breaking approaches to treat enormous global health problems. We offer an exciting and flexible work environment with unique benefits to motivated individuals looking to be part of an energetic team in a challenging field.

Current Open Positions:

If you would like to apply for the available position, please enter your contact information in the Contact box below.

Please check back regularly for updated Job Postings.

Investors
For investors looking to invest in a privately-held, start-up medical device company that offers engineering and medical device product development. Symple Surgical offers ground-breaking therapy of directed renal sympathetic denervation (dRDN).
Extraordinary Business Opportunity:
  • Enormous Global Market Opportunity
    • Approximately 1 Billion People Worldwide have Hypertension
      • 74M Americans
      • 80M Europeans
      • 153M Chinese
    • Direct costs of Hypertension to Global Health Care: < $500B
    • Global Sale of Hypertension Pharmaceuticals > $36B
    • Renal Denervation device sales to reach $500M annually by 2023
    • Medical Ablation Market expected to reach > $4B by 2020
    • Experienced and dedicated leadership and advisory teams
  • Clinical Data supported Therapeutic Efficacy
    • Surgical Sympathectomy for Essential Hypertension in 1950s showed sustained effectiveness in over 1,200 patients with 5-10 year follow-up
    • Over 10,000 patients treated worldwide with Renal Denervation; consistently positive results
    • Excellent long-term safety track record to date, with few adverse side-effects
  • Symple Surgical has a Novel and Superior Device
    • Easy to use device and control system
    • Treats the targeted tissue, preserves the healthy tissue including Renal Artery wall
    • Single Ablation per Renal Artery reduces total procedure time
    • Self-centering antenna and circumferential treatment zone ensures repeatable therapy
    • Only Microwave Ablation System in advanced development
    • 4 US and 3 International Patents Pending; additional applications in-process
  • Promising early stage data
    • Multiple pre-clinical studies complete
  • Exciting Development Horizon
    • Applications for core Microwave Platform in Cardiology, Electrophysiology, Pulmonology, Vascular Specialties and other
    • InSite Renal Denervation System, to offer ground-breaking technology to measure depth specific real-time temperature control intra-procedure.