Access Scientific: Pioneering New Solutions in the Vascular Access Space

Initially trained as a family practice doctor, Bierman spent two decades as an emergency medicine physician at Scripps Health in San Diego. During his many years of direct patient care, he saw patients of all ages subjected to the pain and risk of multiple invasive vascular access procedures, which led him to think about ways to improve that paradigm and positively impact both outcomes and the patient care experience. In 1996, he founded Venetec International, with its now well-known StatLock brand of catheter securement devices. That effort led to a positive exit in 2006 when Venetec was purchased by CR Bard (now part of BD) for $166 million.

Bierman’s latest endeavor, Access Scientific LLC, which he founded in 2011, is also geared toward improving vascular access outcomes. However, rather than focusing on catheter securement as did Venetec, Access Scientific is taking aim at the catheters themselves with an expanding line of next-generation vascular access devices. The company’s best-known products are its POWERWAND power-injectable midline catheters, launched in 2012, which are designed to provide a highly efficacious, yet safer and more patient-friendly alternative to PICCs (peripherally inserted central catheters), surgically inserted central lines, and multiple standard IVs in patients who require longer-term medication delivery.

As is often the case, the technology took a somewhat circuitous pathway to its final destination. The original inventor, an interventional radiologist, envisioned an all-in-one type of vascular access device designed for interventional radiology procedures, and he had attracted some early-stage investment. However, when Bierman was approached by the investors, who hoped he could work his StatLock magic with their device, Bierman didn’t see much of a market for the concept in interventional radiology. However, he did see a big opportunity in the hospital/emergency medicine field. And, what stood out to him in particular was the technology’s potential to positively impact the hospitalization experience for children. Indeed, the prospect of developing safe, extended dwell vascular access catheters that could reduce the number of painful needle sticks children must endure in the hospital—and, for some, enable a “single-stick” hospitalization— was a primary driving force behind his initial decision to take on the venture. “I saw what I thought was a real opportunity to make a giant difference in pediatrics,” notes Bierman, who currently serves as the company’s chief medical officer, “and I just felt drawn into it at that point.”

Extended vascular access has long been problematic in the hospital setting, not only because of the infection risk that accompanies repeated venipunctures and long-dwelling central catheters, but also because many patients, particularly those with chronic disease, have difficult-to-access vessels that make venipuncture problematic.

And unfortunately, PICCs, introduced as a less-invasive alternative to standard central lines, have contributed more to the problem than originally anticipated. PICCs and other central lines are fraught with complications, says Bierman, who notes that over the past four or five years, studies have shown PICC lines are anything but benign. “PICCs were first introduced as innocuous central venous access [devices],” he explains, and their use quickly ramped up. Today, about 2.5 million PICCs are placed each year in the US. However, recent studies show they have risks just like any other central line, including infection, deep vein thrombosis, and other potentially life-threatening complications. “So they should be avoided unless they’re absolutely indicated,” asserts Bierman. According to the literature, central line-associated bloodstream infection rates for PICCs and central venous catheters in the hospital range from about 2 per 1,000 to 5 per 1,000 catheter-days and mortality rates from these infections can be as high as 25%. “Silent” deep vein thrombosis is another common complication, affecting 27%-72% of patients with a PICC.

Although PICCs were overused in the past, Bierman says that is slowly changing. In the past, PICCs were considered a better option than peripheral IVs for delivering mildly acidic medications, such as the antibiotic vancomycin, due to the perceived risk of extravascular tissue injury with peripheral catheters. And, in fact, that misperception persists despite a wealth of new data showing that peripheral IVs, especially midline catheters, can safely deliver such medications with far fewer catheter-related complications. Practice guidelines were changed in 2016 to reflect the new data, which is helping to change clinical practice, notes Bierman. Meanwhile, there are other forces at work that are also incentivizing hospitals to restrain their use of central lines—most notably, diminishing reimbursement due to CMS’ “never event” payment rules that penalize US hospitals for central line-associated bloodstream infections.

As a result, says Bierman, there is now “intense pressure” on hospitals to reduce the number of PICCs and central lines being placed and to find safer alternatives. The question is, what do clinicians turn to instead of a PICC line? They could use a standard IV, he notes, but those typically must be replaced every three to four days (whereas PICCs and central lines often stay in place for weeks or months). Frequent IV changes, another possible alternative, are not only inconvenient, but also subject patients to unnecessary discomfort as well as the infection risk associated with each needle pass through the skin. A better option is a midline catheter, asserts Bierman, who says there is a large and growing opportunity for a new generation of safer midline catheters, such as the POWERWAND midlines , to fill this treatment gap. Midlines are just what the name implies: at up to 20 cm in length, they are longer than a standard IV catheter but shorter than a central catheter. They are inserted peripherally through a large vein in the upper arm and are advanced until the distal tip reaches the basilic, cephalic, or brachial vein just below the shoulder (PICC lines are advanced all the way to the vena cava).

Midlines are ideal for patients who require continuous vascular access over a period of two or three weeks ( POWERWAND midlines are FDA cleared for up to 29 days of use), particularly those who are needle averse or who have difficult-to-access veins that would make repeated needle sticks problematic. (For patients who require months-long access, however, a central line may still be the best option.)

Of note, Access Scientific has had its share of challenges in this space—chief among them, addressing and overcoming some longstanding negative views and misperceptions about midline catheters. When first introduced years ago, midlines were much longer than they are today and they were associated with serious complications that gave the category “a black eye and a bloody nose,” Bierman says. In fact, early midlines that extended midway to the clavicle were associated with “some horrendous complications,” he notes. “In my view, they were poorly designed, by and large, and it was very difficult to identify complications until it was too late.” Access Scientific entered the market in 2012 with what Bierman describes as “a line that was entirely different”—not only much shorter (8-10 cm), and thus safer, than those early midline designs, but also one that pioneered a market segment that did not even exist at the time: power injectable midlines.

The term “power-injectable” refers to a catheter’s ability to accommodate high flow rates and high pressures, an important consideration for some common procedures such as contrast media injection during a CT scan. A 5F POWERWAND, for example, has a maximum gravity flow rate of 180 mL/min, which is considerably higher than the 80 mL/min achieved with standard 18-gauge midlines or the 31 mL/min provided by a 5F single-lumen PICC, the company says. Moreover, when used with a power injector, the device can provide a flow rate of 8 mL/sec at 325 psi, which the firm says exceeds all other power injectable midlines on the market.

But not only are Access Scientific’s POWERWAND midlines able to accommodate high flow rates, they have other attributes that Bierman says make them highly competitive in this space. For one thing, they have a manufactured tip that eliminates the need for catheter trimming and enables them to be advanced over-the-wire, thus reducing the risk of vessel damage that can lead to deep vein thrombosis and back-leaking, the firm says. Another key attribute, according to Bierman: all of Access Scientific’s catheters are made of a unique, inert material called ChronoFlexC, which the company exclusively licenses from Advan Source Biomaterials and then subjects to multiple proprietary secondary processes to render the material kink resistant and strong enough to withstand repeated blood draws. Bierman says the firm suspects that this unique catheter material may also retard bacterial growth, although exactly how it does so is not yet fully understood and is the subject of an ongoing study being conducted in collaboration with the University of California, San Diego.

The end result, he asserts, is a “best-in-class” power injectable midline technology that has outperformed not only the early midlines, but “every vascular access device [currently] on the market.” Indeed, an independent study performed at Methodist Hospital in Indiana involving 2,688 patient-days of POWERWAND midline use, found a 35% reduction in the number of PICCs placed and zero bloodstream infections over the 12-month study period. And that research, presented at the Association for Vascular Access conference last September, is only one of several independent studies that have observed similar results, Bierman says. There have been a total of five peer-reviewed studies published and seven scientific posters presented, he notes, and not one has reported a bloodstream infection related to the POWERWAND midline catheter. “Twenty-three thousand catheter days of usage compounded across these studies without a single catheter-related blood stream infection—that’s never been recorded before,” Bierman stresses. The company says the POWERWAND also has demonstrated less thrombosis/occlusion than other types of lines, resulting in the lowest total complication rate (8.3%), compared with other midlines (9.6-22.6%), peripheral IVs (47%), and PICCs (29%), and the highest rate of therapy completion (89%).

In addition to its line of POWERWAND power-injectable midline catheters, Access Scientific also offers the 3F POWERWAND EDC (extended dwell catheter), launched in 2016 and targeted to the ultrasound-guided IV market as well as the pediatric market (the same device is also sold as the POWERWAND Pediatric catheter). At 6 cm in length, the POWERWAND EDC is longer than a peripheral IV but shorter than a midline and offers 12-14 days of dwell time, which means it may enable a single-stick hospitalization for many patients, including many hospitalized children. In 2017, the company further expanded its product portfolio by launching a line of trauma/anesthesia products, including the POWERWAND REC (rapid exchange catheter), which enables physicians in the ER setting to very quickly exchange a slow-flow peripheral IV for a high-flow POWERWAND device; and a single-lumen, 16-gauge central venous catheter, the POWERWAND CVC, which Bierman says is the “fastest flowing line in the hospital.” Its next product line addition is expected to come in summer of 2018, when the firm plans to launch what Bierman says will be a “vastly superior” arterial catheter, the Arterial WAND.

But, lest anyone think otherwise, it has not been all smooth sailing for Access Scientific since its founding nearly seven years ago. As mentioned, the company worked for years—and continues to do so—to counter misperceptions about the safety and usefulness of midline catheters. The company also experienced some funding challenges early on and in 2012 agreed to be acquired by private equity firm Endeavour Capital (Bierman says Access Scientific has had a host of private investors from the early seed stage on and has certain unnamed institutional investors as well).

It also faces some stiff competition in the vascular access arena from much larger competitors the likes of CR Bard/BD, Teleflex, Angiodynamics, and Medcomp (Medical Components Inc.), which also sell midlines (and power injectables). But Bierman insists that Access Scientific will be able to compete effectively on the merits of its technology, even in a space that most would consider a commodity market. “If you look at the big players in the vascular access world,” he notes, “there are not that many quantum improvements that are happening, other than those driven by Access Scientific. We pioneered the modern age of power injectable midlines, and we’re now pioneering extended dwell catheters and making vital improvements in emergency/anesthesia products, pediatrics, and soon, arterial catheters. And with every product we introduce, the first thing we go after is honest evidence to prove out its superiority to our clients. Who else is innovating like this in the world? I don’t see anyone.”

As for the difficulties of innovating in what many consider to be a commodity market, Bierman asserts that the company’s technology “de-commoditizes” every market niche it enters. “Commodities are differentiated on price, and price only,” he notes. “We differentiate on performance superiority. But in doing so, we also demonstrate, account by account, cost savings in terms of additional reimbursement and the absence of CMS penalties and hidden costs such as bloodstream infections. So there’s big money to be saved as well as big benefits on the patient and the caregiver sides.” Along with those efforts, the company is also pursuing more traditional avenues to compete on cost and recently signed a group purchasing agreement with Premier Inc. that allows Premier members to take advantage of special pre-negotiated pricing and terms on Access Scientific’s line of midline catheters.

“It’s a very competitive market for a host of reasons,” Bierman concedes, “and the clinically superior product doesn’t always win out.” But, he insists, Access Scientific has made a name for itself as the “premier innovator” in this field with best-in-class products in every niche it enters. “There’s no competition when it comes to clinical superiority—I’d be amazed if somebody wanted to argue that point.”