Wednesday, April 18, 2018

Avinger Announces First-in-Patient use of Extended Nosecone Version of Next Generation Pantheris





Source:  Avinger, Inc.


Three patients successfully treated using next generation image-guided atherectomy device with enhanced tissue removal capacity for treatment of peripheral artery disease

Avinger, Inc. (Nasdaq:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced that Arne Schwindt, M.D., a vascular surgeon at St. Franziskus Hospital in Münster, Germany, successfully treated the first three patients with the extended nosecone version of the next generation Pantheris Lumivascular atherectomy system (A400EX). This product is a line extension of the existing next generation platform, with a longer nosecone that enhances the plaque removal capacity of the device in addition to the feature improvements of the next generation of devices. This new device qualifies for commercial sale in the European Union (EU) under the existing CE Marking for Pantheris.

The extended nosecone increases the storage capacity of the Pantheris system by approximately 75%, which should translate to increased procedural efficiency, particularly in long, diffuse lesions with significant plaque burden. Dr. Schwindt, who has now performed 21 cases across all platforms of the next generation Pantheris, used the A400EX to treat a variety of challenging lesion types, including in-stent restenosis (ISR). This device is available in limited supply for commercial sale in select EU countries; it is not available commercially in the United States at this time.

Dr. Schwindt noted, “Despite the difficult nature of these particular interventions, I was able to safely and effectively achieve positive outcomes for these patients using the new version of Pantheris with the extended nosecone. I am excited to continue to use this technology in lesions with higher plaque burden, and continue to see the added benefit of the design improvements incorporated into the next generation Pantheris platform.” 

“We appreciate Dr. Schwindt’s continued partnership with us in our objective to improve physician user experience with our technology while continuing to generate positive patient outcomes,” said Jeff Soinski, Avinger’s president and CEO. “Dr. Schwindt’s feedback will continue to be invaluable as we launch our Pantheris next generation platform in additional sites both in the EU and in the US, once we receive FDA 510(k) clearance.”

Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger’s proprietary Lightbox console. Physicians performing atherectomy with other devices must rely solely on X-ray as well as tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation. 

About Avinger, Inc.Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, California. For more information, please visit www.avinger.com.

 

Avinger Provides Update on U.S. Intellectual Property Portfolio





Source:  Avinger, Inc.


Three New Patents Allowed or Issued for Proprietary CTO Crossing Devices

Avinger, Inc. (Nasdaq:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced three recent additions to its U.S. intellectual property portfolio.
The U.S. Patent and Trademark Office ("USPTO") has issued U.S. Patent No. 9,854,979, titled “Chronic Total Occlusion Crossing Devices with Imaging.” In addition, the USPTO has provided an Issue Notification for U.S. Patent Application No. 13/752,325, titled “Catheter System and Method for Boring Through Blocked Vascular Passages,” which is expected to issue as U.S. Patent No. 9,918,734 on March 20, 2018 and has provided a Notice of Allowance for certain claims in U.S. Patent Application No. 14/433,786, titled “Occlusion-Crossing Devices.”

All three of these patents relate to Avinger’s portfolio of technologies used for crossing completely blocked arteries, also referred to as chronic total occlusions or CTOs, in both the peripheral and coronary arteries. The Company’s Ocelot device is the only image-guided CTO-crossing catheter cleared for sale in the U.S. by the FDA. It demonstrated 97% success in crossing CTOs in peripheral arteries and a 98% freedom from major adverse events in the 100-patient CONNECT II study, which supported the device’s FDA clearance in 2012.

“These positive actions by the USPTO help to establish Avinger’s technology leadership in the field of CTO crossing,” commented Jeff Soinski, Avinger’s president and CEO. “Products covered by these patents provide valuable options to interventional physicians and their patients, in many cases allowing PAD patients to be successfully treated with minimally-invasive techniques rather than surgical bypass.”

Avinger’s extensive intellectual property portfolio now includes 119 patents and applications, including 19 issued and allowed U.S. cases, 23 pending U.S. applications, 29 issued and allowed cases outside the U.S., and 48 pending applications outside the U.S. The portfolio has broad applicability in the areas of atherectomy, CTO-crossing and intravascular imaging.

About Avinger, Inc.
Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, CA. For more information, please visit www.avinger.com.

 

OPS Code Established for Peripheral Vascular OCT Imaging in Germany

 Source:  Avinger, Inc.

New Code is a Potential Precursor to Higher Reimbursement Levels in German DRG System

Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced that the German Institute for Medical Documentation and Information (DIMDI, Cologne) has established a tracking code, known as an OPS code (Operationen- and Prozedurenschluessel), for peripheral vascular optical coherence tomography (OCT) imaging. This tracking code will apply to both Avinger’s Pantheris image-guided atherectomy catheter and Ocelot family of catheters for the crossing of chronic total occlusions (CTOs), which utilize OCT imaging as part of the Company’s proprietary Lumivascular platform. Although no incremental reimbursement has been assigned at this point, the tracking code is in place to gather data that could provide support for higher incremental reimbursement in the future. The next-generation Pantheris system was granted a CE Mark in December 2017. In Germany, hospital treatments are reimbursed through a diagnosis-related group, or DRG, lump sum payment system. The designation of new technologies to be tracked for use and associated costs in the DRG system occurs once each year when the new surgery and procedure OPS codes are made available to the Institute for the Hospital Remuneration System, InEK, Siegburg.

“We are encouraged by the establishment of this code covering OCT imaging performed with our Pantheris and Ocelot catheters, which we believe will allow us to demonstrate additional patient and physician benefits with the goal of establishing increased German reimbursement levels down the road,” said Jeff Soinski, President and Chief Executive Officer of Avinger. “We are also pleased that in supporting this code, the relevant medical societies have confirmed that OCT is a suitable imaging modality for use in the peripheral arteries.”

Atherectomy is a minimally invasive treatment for PAD in which a catheter-based device is used to remove plaque from a blood vessel. Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy procedure by using OCT, which is displayed on Avinger’s proprietary Lightbox console. Physicians performing atherectomy with other devices must rely solely on X-ray as well as tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions through real-time OCT images generated from inside the artery, all without exposing healthcare workers and patients to the negative effects of ionizing radiation. 

About Avinger, Inc.Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, CA. For more information, please visit www.avinger.com.

 


Monday, April 16, 2018

Avinger Announces Closing of $18 Million Underwritten Public Offering

Source:  Avinger, Inc.


Secured Lenders Convert $38 Million of Debt into Equity

Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the closing of an underwritten public offering of Series B convertible preferred stock, together with warrants, for gross proceeds of approximately $18.0 million, prior to deducting underwriting discounts and commissions and offering expenses payable by Avinger. In conjunction with the closing of the offering, the lenders under the company’s term loan agreement, CRG LP and certain of its affiliated entities, have converted $38.0 million of debt into the company’s Series A convertible preferred stock. Following this conversion, the Company will have approximately $6.5 million of term loans, plus any accrued interest since December 31, 2017, due in June 2023. CRG has entered into a one-year lockup agreement relating to all Avinger securities that they hold.

The Series B preferred stock issued in the public offering is convertible into shares of the company’s common stock at a conversion price of $2.00 per share. Each share of Series B preferred stock will be accompanied by (a) a Series 1 warrant, which expires on the earlier of (i) 60 days following the clearance by the FDA of a new lower-profile version of the company’s Pantheris atherectomy system and (ii) the seventh anniversary of the warrant’s issuance, to purchase 500 shares of the company’s common stock at an exercise price of $2.00 per share, and (b) a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 500 shares of the company’s common stock at an exercise price of $2.00 per share.

The company intends to use the net proceeds from this offering for working capital and general corporate purposes, and may also use a portion of the net proceeds to resolve pending legal proceedings.

Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE American:LTS), acted as sole book-running manager in connection with the public offering.
A total of approximately 18,000 shares of Series B preferred stock, convertible into approximately 9.0 million shares of common stock, and warrants to purchase approximately 18 million shares of common stock were issued in the offering.

The securities were offered pursuant to a registration statement on Form S-1 (File No. 333-222517), which was declared effective by the United States Securities and Exchange Commission (“SEC”) on February 13, 2018 and an additional registration statement filed pursuant to Rule 462(b) (File No. 333-223023), which became effective when filed.

The Series A preferred stock is also convertible into shares of the company’s common stock at a conversion price of $2.00 per share. Following the conversion of $38 million of principal amount of loans into Series A preferred stock, approximately $6.5 million of principal, plus accrued interest since December 31, 2017, will remain outstanding under the company’s term loan agreement  with CRG. This term loan will mature in June 2023.

About Avinger, Inc.
Avinger is a commercial-stage medical device company that designs and develops the first-ever image-guided, catheter-based system that diagnoses and treats patients with peripheral artery disease (PAD). Avinger is dedicated to radically changing the way vascular disease is treated through its Lumivascular platform, which currently consists of the Lightbox imaging console, the Ocelot family of chronic total occlusion (CTO) catheters, and the Pantheris® family of atherectomy devices. Avinger is based in Redwood City, CA. For more information, please visit www.avinger.com.

 

Saturday, April 14, 2018

Twin Vee PowerCats Finishes 2017 with Record Year

Source:  Twin Vee PowerCats, Inc.



Twin Vee PowerCats, Inc. (OTC PINK: TVPC), one of the largest production-based dual hull boat companies in the United States, announced today that 2017 was a record year for them. "Not only did Twin Vee see an increase in revenue, but our company also grew by leaps and bounds regarding the products we now offer to an expanding market of first-time and experienced boat owners," says Joseph Visconti, President of Twin Vee PowerCats, Inc. "We have witnessed an increase in the interest of power catamarans over the past year, and that can be seen in the most popular boat models we currently have to offer."

According to Preston Yarborough, Director of Product Development for Twin Vee PowerCats, Inc., Twin Vee's OceanCat 26-foot Go Fish or "GF" and OceanCat 26-foot Sports Edition or "SE" represent two of their most popular boats for sale and also some of the greatest values in the center console market today. Moreover, for approximately $64,500, a buyer can purchase an OceanCat 26-foot Pro, the company's entry-level OceanCat. "All three models handle the open seas like a much larger boat and are built with the same hull that is at the heart of our world-renowned smooth ride," states Yarborough.

Twin Vee OceanCat 260 GF
Twin Vee's other popular models are the OceanCat 310 Pro and OceanCat 360 GF. The 310 OceanCat Pro is approximately $137,500, "Our OceanCat 310 Pro is sold at an amazing price and epitomizes the four things that Twin Vee holds dear: quality, smooth ride, fuel efficiency, and value," says Yarborough.

The OceanCat 360 Go Fish is powered by all-new twin Suzuki AP 350 horsepower motors with contra-rotating three blade propellers. These new Suzuki motors are lightweight and fuel-efficient. Additionally, the 360 GF offers comfort and amenities, such as dual live wells, an over-sized insulated fish box, a twelve-foot beam, and plenty of seating and room to entertain family and friends out on the water. A Twin Vee OceanCat 36' GF can be purchased for approximately $200,000, including hardtop.

Twin Vee Oceancat 360 GF

Visconti has seen a shift in the marine industry as of late. He has heard rumors that several of the top single hull boat manufacturers and seen a couple of them bringing dual hull power catamarans to the market due to their increasing popularity. "A 40-foot Invincible power catamaran is on sale for nearly $600,000, and the Freeman Boat company has catamarans priced in that range as well. This move by the industry at large to manufacture power catamarans simply confirms that Twin Vee has been on the right track since the beginning. For over 23 years, we have been making the best riding boat on the water. That is not just a slogan for us. It is our company's mantra," remarks Visconti.

For Visconti, simple validation by the marine industry is not stopping his company from designing, innovating, and building new Twin Vee boats. His company has made significant investments in new technology to augment the company's traditional hand-built process. Just this past summer, the company purchased an industrial grade 35-foot overhead five-axis computer numerical control ("CNC") router capable of milling a 45-foot plug for new models. Twin Vee utilizes the CNC router to manufacture high-quality plugs and molds to help bring new boats to market by in less time and with less cost to the Company. Visconti states, "We are not resting on our current product success. We are fully utilizing our upgraded manufacturing plant and working night and day to bring ground-breaking offerings, such as our new 230 Center Console, single-engine power catamaran. Our customers can expect this exciting new boat model to be available at all of our Dealer locations within three months."

2018 will be another record-breaking year for Twin Vee PowerCats, Inc., Visconti posits. With various projects involving new boat designs, customer outreach, and industry-changing technological enhancements, Twin Vee has a lot to look forward to in the coming year. "No matter what happens," Visconti makes clear, "The things that will never change at our company is the importance we place on manufacturing the best riding boats on the water at the greatest value for our customers, without sacrificing on the quality we are known for."

Twin Vee PowerCats, Inc.'s Dealers:
Atlantic Boats
2820 Cranberry Hwy
Wareham, MA 02571
(508) 295-8005

Bob and Annie's Marine
3420 Stringfellow Rd
St James City, FL 33956
(239) 283-3962

Brown's Marine
42 Jacks Place
Deltaville, VA 23043
(804) 776-6365

Fort Macon Marina
417 E Fort Macon Rd, Atlantic Beach, NC 28512
(252) 726-2055

Jupiter Pointe Club & Marina
18753 SE Federal Hwy,
Tequesta, FL 33469
(561) 746-2600

Mayday Marine Services
5385 Seminole Blvd, St. Petersburg, FL 33708
(727) 422-9557

Paradise Marine Center
6940A AL-59
Gulf Shores, AL 36542
(251) 968-2628

Specialty Marine Center
720 S Dixie Fwy,
New Smyrna Beach, FL 32168
(386) 410-4757

Three Rivers Marine
1038 N Suncoast Blvd
Crystal River, FL 34429
(352) 563-5510

Wefings Marine
131 US-98
Eastpoint, FL 32328
(850) 670-8100


About Twin Vee PowerCats, Inc.
Headed by CEO Joseph Visconti, originally founded in 1994, the company designs, manufactures and sells recreational and commercial twin-hull power boats under the Twin Vee brand name. Over the past 23 years, the company has concentrated on perfecting the high-speed twin-displacement hull design, also known as a "catamaran powerboat." For more information, go to www.twinvee.com or visit Twin Vee Powercats, Inc.'s Facebook page.

Twin Vee Announces Seven Sports Marine as New Dealer in the Florida Keys

Source:  Twin Vee Powercats, Inc.

Twin Vee PowerCats, Inc. (OTC PINK: TVPC) announces that Seven Sports Marine, a boat dealer in Islamorada in the Florida Keys, has become the newest authorized dealer of Twin Vee's dual-hull, offshore power catamarans for Miami/Dade and Monroe County. "We are happy to have Seven Sports Marine as our latest partner to help promote and sell our smooth-riding boats to residents and businesses in the Florida Keys," says Joseph Visconti, President of Twin Vee PowerCats, Inc.

With three locations along Islamorada, Seven Sports Marine was established in 1999 and continues to be owned and operated by Brad Lange. "The Seven Sports Marine family is eager to offer customers in South Florida the opportunity to experience Twin Vee's power catamaran products for themselves," says Lange. "With multiple locations in Islamorada and a service department that can fix, repair, and salvage just about anything, Seven Sports Marine has the capability to properly support customers before and after their purchase of a Twin Vee boat. We have always been dedicated to selling quality products to the community and believe Twin Vee is the perfect fit for us." says Lange.

Visconti states that Seven Sports Marine's centralized location in the keys, their commitment to the community, and their ability to service Twin Vee boats were crucial in the decision to bring on Seven Sports Marine as Twin Vee's newest dealer. "Finding the right dealer in Monroe County was important to our Company. Once I discovered the significant foundation Seven Sports Marine had established in Islamorada for selling and servicing boats, as well as the positive feedback they constantly receive from their customers, it was an easy decision to partner with them. Twin Vee is always on the lookout for dealers that can provide the kind of comprehensive customer service and satisfaction that Seven Sports Marine has for Monroe County."

Seven Sports Marine and their customers will have the benefit of a Twin Vee that continues to evolve and expand. According to Visconti, upgrades and improvements at Twin Vee's 140,000 square foot manufacturing facility in Fort Pierce, Florida make boat production less strenuous on resources and more efficient on time. "Twin Vee is currently developing new, exciting, and innovative products to remain on the cutting edge of the industry. These new boat models are designed from the keel up on CAD (computer-aided design) and will continue to give Twin Vee the competitive advantage in the fishing and recreational boating industry. Moreover, this will allow our dealers, like Seven Sports Marine, to market the most up-to-date and innovative boats we have to offer to their customers."

The addition of Seven Sports Marine in Miami/Dade and Monroe County, Florida to the Twin Vee dealership network is a major step in the company's goal to expand product awareness in popular marine markets. "Seven Sports Marine helps ensure that Twin Vee's brand is properly represented in a region of Florida where boats are heavily utilized every day," says Visconti. "We're glad to see our boats will have the opportunity to develop greater recognition in South Florida where customers will no doubt be interested in the attractive pricing of our boats, new and updated models of Twin Vee boats that caters to multiple needs, and the one-of-a-kind versatility that comes from our spacious multi-hull design," states Visconti.

Those in Miami/Dade and Florida Keys/Monroe County may contact Seven Sports Marine at (305) 664-4055 or visit their website at www.sevensportsmarine.com.

About Twin Vee PowerCats, Inc.
Headed by CEO Joseph Visconti and acquired March 2016, the Company was originally founded in 1994, the company designs, manufactures, and sells recreational and commercial twin-hull power boats under the Twin Vee brand name. Over the past 22 years, the company has concentrated on perfecting the high-speed twin-displacement hull design, also known as a "catamaran powerboat." For more information, go to www.twinvee.com or visit Twin Vee PowerCats, Inc.'s Facebook page.

Twin Vee Announces Buras Marine as New Dealer in Maryland and Virginia

Source:  Twin Vee PowerCat, Inc.

Twin Vee PowerCats, Inc. (OTC PINK: TVPC) announces that Buras Marine, a boat dealer in the Chesapeake Bay area servicing Maryland and Virginia, has become the newest authorized dealer of Twin Vee's dual-hull, offshore power catamarans. "We are proud to have Buras Marine as our latest partner to help promote and sell our smooth-riding boats to a completely new market of customers," says Joseph Visconti, President of Twin Vee PowerCats, Inc.

Located in Tracys Landing, Maryland, Buras Marine is a family-owned small business operated by Natalie Palugyai and Ryan Buras. "The Buras Marine team is excited to offer Chesapeake Bay residents the opportunity to test drive and purchase Twin Vee's premier power catamaran products," says Buras. "Our company is focused on delivering an exceptional customer experience. For example, Carey Filling, our Sales/Marketing Director, has been boating on the Chesapeake Bay for over 45 years. Like the rest of our team here, he is dedicated to delivering a quality product, matched to his clients' needs, thereby ensuring their total satisfaction with the buying process and boat ownership. Twin Vee and Buras Marine will be quite the team," posits Buras.

Visconti states that Buras Marine's commitment to customer relations was key in his decision to court Buras Marine as Twin Vee's newest dealer. "I was impressed with the emphasis Buras Marine placed on having an active relationship with their customers. The team there is extremely active with dealer events, boat shows, and finishing tournaments - all avenues for customer outreach. That is the kind of partner Twin Vee is on the lookout for; those that ensure that their customers have the best buying experience possible."

Buras Marine and its customers will have the benefit of a Twin Vee that recently went through a major overhaul. According to Visconti, upgrades and improvements at Twin Vee's 140,000 square foot manufacturing facility in Fort Pierce, Florida make boat production less strenuous on resources and more efficient on time. "Twin Vee is currently developing new, exciting, and innovative products to keep on the cutting edge of the industry. These new boat models are designed from the keel up on CAD (computer-aided design) with the help of a former naval engineer. These products will continue to give Twin Vee the competitive advantage in fishing and recreational boating industry allowing dealers like Buras Marine to market the most up-to-date and innovative products we have to offer."
The addition of a Mid-Atlantic dealer to the Twin Vee dealership network is a major step in the company's goal to expand product awareness to new markets. "We have already seen the popularity of Twin Vees in Florida and along the Gulf Coast," says Visconti. "We're glad to see our boats have the opportunity to develop traction and recognition in the Chesapeake Bay area, where customers will no doubt be interested in the attractive pricing of our boats, the wide appeal of our brand from first time boat buyers and seasoned sailors and fishers, and the one-of-a-kind versatility that comes from our spacious multi-hull design," states Visconti.

Those in the Chesapeake Bay area may contact Buras Marine at (410) 220-0504 or visit their website at www.burasmarine.com.

About Twin Vee PowerCats, Inc.
Headed by CEO Joseph Visconti and acquired March 2016, the Company was originally founded in 1994, the company designs, manufactures, and sells recreational and commercial twin-hull power boats under the Twin Vee brand name. Over the past 22 years, the company has concentrated on perfecting the high-speed twin-displacement hull design, also known as a "catamaran powerboat." For more information, go to www.twinvee.com or visit Twin Vee PowerCats, Inc.'s Facebook page.

Friday, April 13, 2018

Twin Vee PowerCats Purchases a Second 30-foot Gantry CNC 5-Axis Router





Source:  Twin Vee PowerCats, Inc.

Twin Vee PowerCats, Inc. (OTC PINK: TVPC) announced today that it purchased a five-axis overhead gantry computer numerical control ("CNC") router from Diversified Machine Systems. This is the second router Twin Vee has purchased since the acquisition of the Company two years ago. The gantry router will be installed in its factory in Fort Pierce, Florida.


Joseph Visconti, President of Twin Vee Powercats, Inc., stated, "This is an important investment in the required technology and automation to move Twin Vee forward as a leading designer and manufacturer of multi-hull boats. PowerCat boats are finally attracting the attention from recreational, commercial, and pro boaters. Having two gantry routers running full-time, milling Twin Vee's new line of PowerCats, will cut the' design to production to market' time in half. The marine industry is moving ahead by leaps and bounds with technology, design, and power and we intend to be in the front of the pack when it comes to innovation and production of affordable, multi-hull boats. The demand is growing. Our second gantry CNC router and our expanding dealer base will allow Twin Vee to meet this demand."

Visconti has discovered several competitors that have traditionally only produced mono-hulled boats have begun offering dual hull power catamarans due to their increasing popularity. "This move by the industry-at-large to manufacture power catamarans simply confirms that Twin Vee has been on the right track since its inception. For over 23 years, we have been making the best riding boat on the water. That is not just a slogan for us. It is our company's mantra," remarks Visconti. "Our newest CNC router offers us the ability to increase our production capabilities and ensure we outpace our competitors."

Twin Vee has made significant investments in new technology to augment the company's traditional hand-built process. Last year, Twin Vee purchased its first industrial grade 35-foot overhead five-axis CNC router capable of milling a 45-foot plug for new models. Twin Vee will utilize both CNC routers to manufacture high-quality plugs and molds to help bring new boats to market by in less time and with less cost to the Company. Visconti states "with the purchase of a second CNC router, we are realizing our Company's full production potential in our newly upgraded manufacturing plant and working night and day to bring new and ground-breaking offerings."

With the help of its newest CNC router, Twin Vee's Product Development Department has been hard at work designing and building an entirely new line of Twin Vee PowerCat models. The Company is designing and building the all-new 230 JP CC "Center Console," the 230 Herou-X DC "Dual Console, a 27-foot OceanCat Center Console boat, as well as completely redesigning Twin Vee's most popular boat, the OceanCat 260. "These all-new PowerCats will be introduced over the next several months, something that would not have been possible without the CNC routers we've purchased." Preston Yarborough, Director of Product Development for Twin Vee Powercats, Inc., adds.

Computer-generated example of Twin Vee's 230 Herou-X DC "Dual Console"

For Visconti, the Company's Best Riding Boat on the Water mantra is one that requires Twin Vee to never stagnate and to strive to always improve itself. "The strides we've made in the overhaul of our manufacturing process means that we can now more easily innovate and reimagine our boats to cater to an expanding marketplace looking for dual-hulled boats. The new technology we have incorporated into our production facility in Fort Pierce, like the two CNC routers, elevates us to a new level and provides us with a distinct competitive advantage in our industry," states Visconti.

About Twin Vee PowerCats, Inc.
Headed by CEO Joseph Visconti and acquired March 2016, the Company was originally founded in 1994, the company designs, manufactures, and sells recreational and commercial twin-hull power boats under the Twin Vee brand name. Over the past 22 years, the company has concentrated on perfecting the high-speed twin-displacement hull design, also known as a "catamaran powerboat." For more information, go to www.twinvee.com or visit Twin Vee PowerCats, Inc.'s Facebook page.


Friday, April 6, 2018

IGF Oncology Drug Summary

Source:  IGF Oncology, LLC

Lead Drug IGF-MTX

• Insulin-like growth factor variant protein attached to the chemotherapy drug methotrexate.
• Targets a receptor protein, IGF-1R, overexpressed on cancer, so it is a targeted chemotherapy that selectively targets and kills cancer cells and has less effect on healthy cells.
• Approximately 13 times more effective than methotrexate in mouse model of solid tumor cancers.

 

Phase 1 human clinical trial results: 

 

• Effective at a surprisingly low dose, about 12 times lower dose than the minimum dose methotrexate is usually used at.
• One Hodgkins lymphoma patient whose cancer progressed on standard drugs is now cancer free after treatment with IGF-MTX.
• Efficacy in three other solid tumor patients.
• ZERO decrease in blood cell counts, the most important side effect of standard chemotherapy.
• Opening a Phase 2a clinical trial at Mayo Clinic in the blood cancer myelodysplastic syndrome (MDS) in January 2018.
• MDS is a deadly blood cancer with no very effective treatments.
• Only two currently approved drugs for MDS, and they don’t work very well.
• IGF-MTX kills MDS cells in the laboratory and is synergistic with the most commonly used of two approved drugs.
• IGF receptors are overexpressed on MDS disease cells.
• IGF-MTX is well suited for this disease because the patients cannot tolerate any decrease in blood cells, and unlike all other cancer chemotherapy, IGF-MTX does not cause any decrease in blood cells.

 

Second drug: CPE-54

 

• An engineered food poisoning toxin.
• Binds to a target overexpressed on ovarian cancer and other cancers.
• Well suited for late stage ovarian cancer because it kills late stage ovarian cancer cells better than early stage, unlike all other drugs.
• Clinical trial planned to begin in 2018.


IGF Oncology Intellectual Property Summary

Source:  IGF Oncology, LLC

US Patent No. 7,811,982 and family covering 765IGF-MTX

IGF Oncology owns U.S. Patent No. 7,811,982, which claims broadly variants of IGF-1 conjugated to anti-cancer chemotherapeutic agents. The variants of IGF-1 are those with reduced binding affinity for the soluble IGF-binding proteins. The claims encompass but do not name or disclose the 765IGF variant and the 765IGF-MTX conjugate. Methotrexate is specifically claimed as a chemotherapeutic agent portion of the conjugate. This patent has a 770 day extension for USPTO delays, and so expires in about December 2026, with further extensions of time available for time in clinical trials and FDA approval. Other patents in this family are US Patent Nos. 9,011,880 and 8,501,906. We have issued foreign patents in this family in Canada, UK, France, Germany, and Japan.

U.S. Patent No. 9,675,671 and family covering 765IGF-MTX and 765EGF-bendamustine

This patent is directed to the 765IGF protein and the 765EGF protein, which are our proprietary variants of IGF-1 and EGF respectively, and it covers other cytokines with the same or related N-terminal segment as is used in 765IGF and 765EGF. This patent will expire on January 12, 2035, with extensions possible for time spent in clinical trials and FDA review. An allowed divisional U.S. patent claims the chemotherapeutic conjugates to 765IGF and 765EGF, specifically including 765IGF-MTX and 765EGF-bendamustine. Foreign patent applications in this family are filed in Japan, India, Korea, Canada, Australia, and Europe.

U.S. Patent Nos. 8,017,102 and family

This patent claims conjugates of toxins (as contrasted with chemotherapeutic agents) with variants of IGF-1 having reduced binding affinity for the soluble IGF-binding proteins. The other patent in this family is U.S. Patent No. 8,920,777. We have issued foreign patents in UK, Germany, and France in this family.

U.S. Provisional patent application 62/509,150, covering method of treatment for using 765IGF-MTX to treat myelodysplastic syndrome.

This provisional patent application will be converted to a regular U.S. utility patent application and international patent application in 2018. When patents are issued on these, they would have patent term extending to at least 2038.

Patent applications to be filed to cover CPE-54 specifically as a composition, and a method of treating cancer

We intend to file patent applications for these two new inventions in 2018. Issued patents based on these would expire in 2038 most likely. These will be assigned to IGF Oncology, LLC.

U.S. Patent No. 8,664,184, and family, licensed from Yale University and the Univ. of Arkansas, covering use of CPE to treat ovarian and uterine cancers and peritoneally located cancers

This patent has claims covering use of CPE to treat ovarian and uterine cancers with CPE or a variant thereof, optionally by peritoneal administration. Other patents in the family are U.S. Patent Nos. 9,702,010, and 8,247,371. They expire on October 12, 2025, with possible extension for time in clinical trials and for FDA approval. U.S. Patent No. 8,247,371 also has a 638 day extension for USPTO delays. These are all licensed from Yale University. U.S. Patent No. 7,927,795 is for diagnosing or monitoring ovarian cancer by detecting overexpression of claudin-3 or -4 or many other genes. It has the same inventor, Dr. Santin, and is assigned to the Univ. of Arkansas and licensed from them.


IGF Oncology




Source:  IGF Oncology

The mission of IGF Oncology is to develop and bring to patients new targeted cancer chemotherapy drugs that have reduced side effects and improved effectiveness compared to existing chemotherapy cancer drugs.

Our lead drug is IGF-MTX and we are in clinical trials at Mayo Clinic and elsewhere in a deadly blood cancer called Myelodysplastic Syndrome (MDS). There are currently no very effective drugs for MDS blood cancer. If our drug proves to have even modest efficacy, it will be more effective than anything on the market and will win FDA approval.  Once IGF-MTX proves effective against MDS, we will target other cancers.



Clinical Trials

Management Team 

Hugh McTavish
Ph.D., J.D.,CEO, & Founder


Dr. Hugh McTavish is a practicing patent attorney and a Ph.D. biochemist with extensive experience in the laboratory. He is also the inventor of the company’s technology. Dr. McTavish is the lead author of several refereed scientific publications, and the inventor of several issued patents and pending patent applications. He received his Ph.D. in biochemistry from the University of Minnesota in 1992, and his J.D. from the University of Minnesota in 2001.


Arkadiusz Dudek
M.D., Ph.D., Chief Medical Officer

Arkadiusz Dudek is Professor of Hematology/Oncology and Director of Oncology Clinical Trials at the University of Illinois Chicago.

Dr Dudek has over 18 years of cancer clinical research experience, over 18 years in the clinical management of mesothelioma, lung cancer, kidney cancer, and malignant melanoma, and over 13 years in the field of tumor angiogenesis, signal transduction, and cancer immunotherapy. His expertise is in design and execution of clinical trials for cancer therapy with a special interest in the development of novel cancer therapeutics. He has 17 years of serving in several leadership positions in clinical trial offices at the University of Minnesota and the University of Illinois. He chairs and manages a broad range of clinical trials (from phase 1 through phase 3, from cooperative group, investigator-initiated, and industry sponsored studies) that are either therapeutic or non-therapeutic studies.

Ronald Way
Board Member

Former U.S. Senate staffer and journalist. Current board member for several medical device and pharmaceutical companies.




Kathleen Littrell
Senior Director Clinical Operations

Has more than 20 years of experience in all phases of clinical trials.