Combat Ready Clamp (CRoC) Makes Tactical Medicine History

FAYETTEVILLE, NC – The Combat Ready Clamp (CRoCTM) made history on May 3, 2013 when it received new critical indications from the FDA making it the first device of its kind approved to treat unmanageable amputations and pelvic wounds not addressable with standard limb tourniquets.

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The CRoC is a vise-like tourniquet now approved for use on all five anatomical junctions where life-threatening hemorrhage can occur in the result of such actions as roadside and terrorist bombings.

Uncontrolled bleeding is the leading cause of preventable death in combat and remains the top focus of tactical medicine.

Approximately 25 percent of potentially survivable deaths are due to uncontrolled junctional bleeding. According to an upcoming study in the American Journal of Emergency Medicine, more than 800 U.S. military personnel have been hospitalized with these types of junctional injuries during the recent wars in Iraq and Afghanistan. More than 150 personnel suffered from upper extremity injuries, 25 of whom died of their wounds. Friday’s FDA clearance will now allow the CRoC to be put to use in every compressible, junctional emergency situation.

Combat Medical Systems of Fayetteville, N.C., maker of the CRoC, recognized the need for an atypical tourniquet device and has worked extensively with the U.S. Army’s Institute for Surgical Research in San Antonio, Tex., and with the Wake Forest University Baptist Medical Center in Winston Salem, N.C., to ensure the device’s clinical efficacy.

“The CRoC is the first device available to treat junctional hemorrhage of the upper extremity on the battlefield or anywhere else, and Combat Medical Systems continues to lead the way in the best care for the nation,” said Dr. John Kragh of the U.S. Army. “We in the military also continue to be impressed with their team which includes Wake Forest University in their commitment to the best care for these casualties.”

The Committee on Tactical Combat Casualty Care (CoTCCC) recommends the device, which applies in seconds. It has already shown life saving success in limited use in Afghanistan as well as multiple Life Flight cases in the U.S.

“Everyone at Combat Medical Systems is excited about this recent news,” said Chris Murphy, Vice President of Research and Development. “This has certainly been a team effort. The support we have received from the USAISR and Wake Forest University has been invaluable in our efforts to deliver this on-of-a-kind device. But it is the early adopters, the military leaders and most importantly our great military medics and corpsman that serve our fallen every day that deserve the most credit.”

Combat Medical Systems was founded in 2008 by a team of experienced military medical personnel and industry product specialists with a mission to simplify tactical medicine. Headquartered in Fayetteville, N.C., nearby Ft. Bragg acts as its catalyst to staying current with medical trends and product development. www.combatmedicalsystems.com

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Combat Medical Systems Awarded $86 Million DOD Contract

FAYETTEVILLE, NC – Combat Medical Systems, a leading developer and distributor of medical solutions, received a five-year $86,000,000 contract with the DoD this week for its variety of tactical medical equipment and devices.

The Defense Logistics Agency announced the award Monday. The contract is specified for DLA’s Medical Electronic Catalog (ECAT) that delivers more than $16,000,000 of medical equipment monthly to U.S. military and federal agencies serving around the world.

“We are extremely proud to have been awarded this contract,” said CMS President, Corey Russ. “ECAT is an important channel of procurement for our customers and continues to strengthen our relationship with the DoD and the other federal agencies we support.”

Included within the contract are CMS specifically developed and distributed products designed to meet the continuing challenges faced by medics and first responders. Among these items is its Mojo line of products and Combat GauzeÔ, the DoD standard in first-line treatment for life-threatening hemorrhage. CMS is the exclusive military distributor for the Z-Medica manufactured hemostatic fielded to every service member in the DoD and authorized in every Individual First Aid Kit (IFAK), Combat Life Saver bags and medical/corpsman kits.

Contracted products also include the AutoMedx SAVeÔ Ventilator, Vidacare EZ-IO Intraosseous devices, and their AllEvacÔ line of evacuation equipment offered with partner Ferno Military Systems, among others.

“We listen intently to our end users and continue to work closely with military leaders, program managers and DLA in an effort to serve as a DoD partner in tactical medicine. We are confident that our collective efforts will continue have a dramatic impact on the survival rate of our service members and federal agents who find themselves in harm’s way,” said Russ. “This award is yet another way to get these lifesaving products in the hands of those who brilliantly put them to use on a daily basis.”

Combat Medical Systems was founded in 2008 by a team of experienced military medical personnel and industry product specialists with a mission to simplify tactical medicine. Headquartered in Fayetteville, N.C., nearby Ft. Bragg acts as its catalyst to remain current with medical trends and product development. http://www.combatmedicalsystems.com

Trexpo East New Product Reviews

Airlie Center
Airlie Conference Center is your secure meeting place. Since 1959 we have hosted meetings that have helped shape our nation. In 2009 and beyond we will continue to provide that environment while respecting privacy and confidentiality.

Colt Defense LLC
The Colt LE6940 is the Tactical Operators answer to demanding situations. The advantage is unmatched. Built to MIL-SPEC standards, no other company combines the quality and craftsmanship that Colt Defense does.

DSM Safety Products LLC
Offering a revolutionary new officer safety product to assist identifying non-uniformed officers involved in critical situations, giving them 360 degrees of visible identification to avoid tragic “blue on blue” shootings.

International Cartridge
International Cartridge, although dedicated to producing lead-free frangible ammunition, is now producing .223 caliber 55 grain full metal jacket ammunition to meet the needs of government and law enforcement agencies.

N-Vision Optics
MTS is a new thermal imaging camera which offers unsurpassed performance when used for surveillance, search and rescue operations, perimeter control and vehicle identification. Regardless of ambient light conditions, smoke or haze, MTS detects even the slightest temperature differences of everything in the field of view and provides the user clear “white hot” or “black hot” images of what otherwise would be invisible to the naked eye.

Patriot3, Inc.
Introducing the G2. Patriot3’s newest innovative addition to its X-treme Protection Series of ballistic shields. The XPS-G2 incorporates Patent Pending features that significantly improve shield mobility and transportability. One of the key features of the G2 is its ability to fit through doorways and then, with the push of a lever, expand its Ballistic Wings to provide the widest area of protection available by any NIJ 4 threat protected shield. The XPS-G2 is available in Threat Level NIJ 3 and NIJ 4, measures 75″ H x 31″ W (base unit dimensions) and is available with such options as Ballistic Extension Wings (available in 12″ (NIJ 3&4) and 18″ (NIJ 3), Gun Port and LED Light System. The XPS-G2’s unique A-Frame support structure provides excellent stability and mobility and collapses for quick and easy transport. The XPS-G2 is the ideal multi-use protective device for stationary and mobile response. This product has a US Patent Pending Status and Patriot3 is the Sole Source Supplier for the XPS-G2.

PT Armor, Inc.
New .06 standard armor.

Simulator Systems International – Robotics Division
Remote controlled, low-profile mobile robot, with 4 axis manipulator arm, designed to perform inspection and reconnaissance in difficult and hazardous environments by remote field operatives. Weighing under 30lb. including manipulator arm, it is back packable.

SOG Specialty Knives & Tools
The new PowerAssist takes multi-tools to a new level. It houses two SOG Assisted Technology™ blades, five components, heavy-duty pliers, large wire cutters and uses patented Compound Leverage. Matte black finish for low reflectivity.

S.O. Tech / Special Operations Technologies Inc.
Tactical Mission Planning Set (TMPST)

The TMPST is designed using magnetized tiles on a flexible magnetized dry erase panel which can be hung from grommets or laid out on the hood of a vehicle. Dry erase markers can be used to draw building layouts, terrain and movements. Magnet symbols can be written on with erasable markers and magnets can be placed on a sand table or magnetic white board where the operational environment can be sketched and movements drawn. Set includes magnetized tiles, dry erase panel and markers in a convenient carry pouch.

The O’Gara Group, Sensor Systems Division 
The Universal Flip Optic accessory provides operators the ability to rapidly refocus their night vision view from infinity to approximately 24 inches. The Universal Flip Optic is compatible with many currently fielded night vision goggles.

The Conformal Enhanced Heads-Up-Display (CEHUD) accessory conforms to the rear of a standard helmet and provides operators with overlaid color or monochromatic images displayed directly into their AN/PVS-21 Low Profile Night Vision Goggles or Dayviewers.

VentureTec LLC
“UtilityCam” for law enforcement surveillance. Provides up to three weeks of motion activated surveillance. Includes 30 Gig hard drive, .003 lux camera, built-in display with remote control.Components will provide years dependable covert video surveillance.

Wiley X, Inc.
DURTAC: Maximum hand protection without compromise. This synthetic multi-use glove is built for everyday duty. Heavy duty moisture wicking lycra, ventilated fingers, & a thermoplastic knuckle protector for impact and abrasion resistance, makes this one tough glove.

Battlefield Medicine

According to many medical professionals, combatrelated traumatic brain injuries (TBI) are becoming a signature injury of the Iraq and Afghanistan wars. Hemorrhage and head injury are the two greatest causes of death on the battlefield.

U.S. Special Operations Command is currently working with industry on innovative ideas in terms of equipment and material regarding the SOF Tactical Combat Casualty Care Increment II-CASEVAC, said Major Wes Ticer with USSOCOM Public Affairs.

Army Medical Research and Materiel Command (MRMC) has achieved significant improvements in controlling hemorrhage from wounds on the surface of the body and from the legs and arms. ‘We are still struggling to identify an effective non-surgical technology to stop internal bleeding,” Colonel Dallas Hack, combat casualty care director at MRMC, told SOTECH. “Furthermore, hemorrhage is often so severe that a casualty must be resuscitated by infusing fluid to maintain blood pressure and oxygen delivery to vital tissues. Finding the best method to resuscitate a casualty is challenging because hemorrhage is not only characterized by the loss of blood, but by activation of a large number of body responses which attempt to compensate for the loss of blood.”

Many of these responses include alterations in body systems such as immune, inflammation and blood clotting functions. Despite decades of research into the best method and fluid(s) to resuscitate a casualty, a fully effective method to replace fluid volume while also correcting the altered body functions has not yet been identified, Hack said.

MRMC’s two major concerns about TBI center on its diagnosis and treatment. It is important to diagnose the occurrence and severity of a TBI, since this information will be used to guide how the casualty is managed. “An ongoing concern is that TBI occurrence and severity, specifically with respect to mild TBI (aka concussion) cannot yet be objectively identified in the field, although significant progress is occurring in development of devices and biological assays to address this challenge,” Hack said. Traumatic brain injury is an event, much like a heart attack. In a heart attack doctors can identify the underlying pathologies of coronary artery disease and its effects. However, Hack said TBI is characterized by a variety of alterations in cellular structure and function, which progress for days, weeks and sometimes months and years after the injury. “While a tremendous amount of research is currently ongoing into the pathology and treatment of TBI, no therapies to prevent the altered cellular function or to repair neural tissues are presently available to treat our casualties in the field, where treatment is most beneficial,” he said. “Treatment for mild TBI is symptom-based.”

The Army MRMC has a long-standing and productive relationship with the PEO soldier who is responsible for acquiring and fielding soldier protective equipment, such as body armor and combat helmets. The command contributes to the development of soldier protection equipment by conducting medical research to develop injury criteria, design standards and protection equipment performance testing methods for PEO soldier.

The command’s mission with respect to the development of new soldier protection equipment is to provide PEO soldier with injury criteria, design standards and protection equipment performance testing methods. PEO soldier uses these medical research products to develop performance specifications for new protection equipment. In addition to the injury prevention considerations provided by the command, these performance specifications also include a wide spectrum of other critically important performance considerations, such as ballistic protection and the ability of the soldier to effectively perform required tasks while wearing the protection equipment. Ultimately, Hack said industry’s challenge is to design and build protection equipment that meets or exceeds these specifications.

MRMC needs from industry “improved equipment and methods to diagnose and treat hemorrhage and TBI, particularly those that can be used in the field as soon after injury as possible,” Hack said. “Even after the original injury occurs, it will be possible to protect against the ongoing damage to tissues caused by altered body/cellular functions.”

The command’s medical research programs have provided the PEO soldier with information needed for the development of effective soldier protection equipment. For example, the command’s research on head-supported mass provided design guidelines to ensure that the weight and placement of helmet-mounted equipment, such as night vision goggles, are optimized to prevent neck injuries. Research on behind body armor blunt trauma is providing a new method for accurately testing the effectiveness of body armor in preventing behind armor blunt injuries. Finally, current research projects within the command and across DoD are examining the existence and mechanisms of non-impact, blast-induced mild TBI, or concussion, and the findings from these projects will help PEO soldier design the next generation combat helmet.

EPIC Helmet Liner

Team Wendy LLC is one company that makes a product to protect soldiers’ heads during blast occurrences. Their latest product is the EPIC helmet liner system: EPIC standing for enhanced protection, individual comfort. This product is an evolution of their current Zorbium Action Pad (ZAP) system, using the same patented Zorbium foam that has been proven through years of use by U.S. servicemembers in Iraq and Afghanistan. The current ZAP system is the only helmet pad system authorized for use in the ground combat helmets worn by members of the U.S. Army (Advanced Combat Helmet) and Marine Corps (Marine Lightweight Helmet), said Ron Szalkowski, senior product development engineer at Team Wendy.

The ZAP system uses seven separate pads, or eight in the SOF configuration, to better accommodate communications gear. These pads are attached to the inside of the helmet shell. “Each pad in the ZAP system has two different layers on the inside—one is firmer and provides impact protection, and the other is soft and provides comfort and stability,” said Szalkowski. “The EPIC system is different in that it includes a single impact liner that folds to the inner contour of the shell and covers nearly the entire inside surface. This makes the impact liner impossible to install incorrectly, for example in a way that hardware may become exposed, or that a large gap could occur between the pads.” Once this one-piece impact liner is installed, there are soft comfort pads that are attached to it in any configuration the wearer chooses. Each system includes 22 of these comfort pads, with thin and thick pads of various sizes and shapes. This allows every helmet to be custom fit.

The comfort pad set also includes two types of specialty pads. The first is the Ultra Grip pad, which has a high-grip surface designed for added stability. The pads are especially effective when using NODs (night observation devices). Four Ultra Grip pads are included with every system. The other specialty pad is the sweatband, which is wringable and highly moisture absorbent. Two sweatbands are included with every system.

Team Wendy designed the EPIC system so that even when no comfort pads are installed it will surpass the impact requirements of the ACH and LWH. “Impact testing involves measuring G-forces experienced by the head during an impact, with higher forces correlating to an increased risk of severe TBI,” said Szalkowski. “The EPIC design has shown a significant increase in protection by reducing high-G impacts without adversely affecting weight or heat dissipation.”

Team Wendy’s future developments are highly focused on improved energy-absorbing materials for helmet applications. They are currently conducting development under a Phase I small business innovation research (SBIR) award from the U.S. Army that aims to develop a material that will take impact protection to the next level. They are closing in on a system that could handle three times the energy input of the current pad systems. This is equivalent from increasing the impact speed from 6.8 mph to 11.8 mph while providing the same level of protection against brain injury.

Combat Gauze Z-Fold

The Combat Gauze Z-Fold is the only hemostatic agent currently recommended by the Committee on Tactical Combat Casualty Care (TCCC). It is issued one per every soldier, three per every combat lifesaver and five per every medic. “Combat Gauze requires little more training than a soldier already has to pack gauze into a bleeding wound and apply pressure,” said Jessica Perkins, CEO at Combat Medical Systems LLC. “It was tested by both the Naval Medical Research Center and the U.S. Army Institute for Surgical Research in 2008, and found to be the best solution for non-tourniquetable hemorrhage due to its efficacy and form factor ease of use. It was also awarded as one of the top 10 greatest inventions by the U.S. Army in 2008.”

According to the U.S. Army Institute of Surgical Research, hemorrhage accounts for 50 percent of the deaths among combat casualties, and a high percentage of these deaths are potentially preventable with prompt and effective treatment of hemorrhage. The development of combat gauze offers the medic a simple, cost-effective hemostatic product to treat severe external bleeding, especially in areas where a tourniquet cannot be applied. It is a large-sized flexible roll of non-woven medical gauze impregnated with a contact pathway activating clotting agent known as kaolin. The dressing can be used on surface wounds and has been proposed to treat deep bleeding at the end of a long wound tract.

“The Combat Gauze Trauma Pad is designed to address an unmet need: provide reliable hemostasis for large soft tissue wounds. With blast being the main mechanism of injury in our current conflict, there are often times large shark bite type wounds that require a large surface hemostatic solution,” said Perkins. “The Trauma Pad addresses this need. It is built on the same kaolin technology of Combat Gauze, but covers more area at once and is easy to apply. Its 12 inch by 12 inch configuration allows it to adequately address bleeding from blast and large surface wounds.”

HEADS Sensor

BAE Systems has been developing technologies designed to better monitor soldiers and identify their risk levels for combat-related TBIs since 2008, when the company first introduced its HEADS sensor. Since then, close to 7,000 of the company’s HEADS units have been fielded to the U.S. Army.

BAE Systems recently unveiled its next generation head-borne energy analysis and diagnostic system (HEADS) sensor. The HEADS sensor, like its predecessor, provides medical professionals with a detailed analysis of a blast/impact by recording accelerations and atmospheric pressures associated with a significant event such as an IED explosion. The HEADS device itself is a small, unobtrusive sensor which is easily secured inside a standard issue combat helmet. The HEADS package is extremely sensitive and is automatically activated when it senses an event. The sensor then records critical data—information identifying the severity of the impact—and stores the data until it can be easily and quickly downloaded.

The latest HEADS sensor stands apart from other systems because it is equipped with an LED visual display that automatically will begin flashing once a predetermined impact threshold has been met. Medical professionals and/or soldiers will know immediately if a soldier has sustained a concussion or worse. Additionally, the new system also incorporates radio frequency identification technology.

When asked about the difficulty often associated with identifying combat-related TBIs (soldiers will sometimes continue with their mission, unaware that the concussion from a blast may have lingering effects), Greg Kraak, director of V. S. military programs, security and survivability at BAE Systems, said, “With the next generation HEADS system, even if the injury isn’t obvious, a soldier will know instantly—via a visual LED display on the helmet—if they, or a fellow soldier, may have sustained a brain injury.”

In addition to alerting soldiers of possible concussions, the HEADS smart sensor is designed to provide medical professionals with important data that may help determine the severity of a soldier’s TBI, as well as treatment options. “With our next generation HEADS system, we’re providing medical teams with a valuable diagnostic tool that utilizes radio frequency technology,” Kraak said. “With our new ‘smarter’ sensor, if a soldier experiences a concussion in the field, not only will the visual display be triggered at the time of the event, but once a soldier enters a specified area, such as a forward operating base or dining facility, a series of strategically placed antennae will scan all available HEADS units and send data to a computer, identifying any soldiers who may have sustained a blast-related brain injury.” ?

Combat Gauze helps Save Life

DUBLIN — Standing tall among the fallen this nation will honor Monday are the great men and women who have paid the ultimate price in the war on terror. This month, the American casualty list in Afghanistan reached 1,000-deep.
Not included is Dublin resident Sean Clifton, who is married to Delphos native Sarah (Langhals). He is a career soldier with 16 years tucked away in his rucksack. He invested close to six years active Army before enlisting in the Ohio National Guard.

SFC Clifton is part of what he calls the best-kept secret in the military — a special forces unit of the National Guard; Co. B, 2nd Bat., 19th SF group. Clifton did two tours in the Middle East in which his duties as an intelligence specialist were to gather information on the enemy — both the Taliban and various local militia.
Clifton was in Afghanistan when critically wounded in a firefight with the Taliban on Memorial Day 2009. Various internal organs were damaged by a bullet that entered below his body armor and exited his upper right thigh. Another round shredded his left forearm and wrist. Clifton’s life hung in the balance as medics tended to him while taking fire from every direction in an eastern Afghanistan village.
“We were conducting a direct-action raid against a known Taliban commander in one of the districts in our province. It was similar to many other missions we had conducted. We were trying to get our partnered nation force, the Afghan National Police, to conduct a large part of this mission in order to prepare them to ultimately conduct missions on their own. In essence, we train with and fight with the local force,” he said.
“We had set things up for them to conduct the entire mission, which was to go into a village and raid a specific compound to capture or kill the target. So, the ANP got into the village and started the mission but it got out of hand for them. So, they called us in to help them out but really, we needed to take over and finish it for them. So, on our way into the village, they were already engaged in a firefight with the local Taliban that controlled the village. We had to do some things to secure the area before we could get into the target building,” he said.
Clifton selected a team of Afghan nationals and took control.
“I grabbed one of the ANP squads and started to clear several buildings looking for our target while some of the other guys on my team secured areas we were getting fired on from. Two of three buildings had been cleared. So, I grabbed 4 or 5 ANP fighters and led them into the third building,” he said.
“On the way into the compound, I kicked the door but it didn’t quite give. When I kicked it the second time, it opened and I was met with a wall of fire. We had thought there would be 3-5 fighters in there with the Taliban commander we were after. As it turned out, there were a couple commanders in there guarded by 22 fighters in that room. So, I walked into what we call a ‘fatal funnel.’ I was stuck in that doorway with all guns firing on me. I was hit at least 4 times; two of the shots hit my body armor — one of them center mass and the other knocked my night vision goggles off of my helmet. The other two rounds were critical. One hit me right beneath the body armor; it entered my lower left waistline and exited the upper right thigh. It punched right through my abdomen, intestines, bladder, damaged my kidney and sciatic nerve. The last round hit my left forearm and shattered it. That’s when I knew I was in bad shape because my arm just crumpled over and my rifle dropped. I was still in the doorway and I knew I had to get out of that situation,” he said.
Clifton stayed focused as adrenalin coursed through his veins.
“As I was shot, I stumbled backward by the force of the rounds. I spun around to get out of there and moved away from the building. The ANP fighters fired into the doorway to take care of the situation and continued to clear buildings. I took about 10 steps away from the building and just so happened to find one of the team’s medics. I walked up to him and said ‘I’m shot, I’m shot’ and he could see that I was holding my left arm. He applied a tourniquet to control the bleeding with my arm and wrist. At that point, that wasn’t a concern — that was a quick fix; we just had to control the bleeding. The abdominal shot was the bigger issue. He coudn’t see it and I didn’t know how bad it was but I knew I had been it below the waist. All of this was going on while we were taking fire from 360-degrees and multiple levels in this small village where all guns were drawn on us,” he said. Chaos is handled by everyone staying focused and doing their job. The medics ministered aid to Clifton while the national police cleared buildings. Meanwhile, the commander called for a Medivac flight.
“They had me in the village for about 20 minutes or more while they worked on the entry and exit wounds — basically, they had to pack me full of gauze and combat gauze to control the bleeding and get an I.V. started. Immediately, a call went out on the radio that I had been shot. So while the medics worked on me, the commander called in the Medivac flight. Those guys were on top of us in 20 minutes and lifted me out of there. The flight surgeon and medic continued working on me while they flew me to the nearest trauma center 30 minutes away,” he said.
The damage was significant. It was “touch and go” for two days.
“Two surgical teams cut me open to close off all the bleeders. I stayed there for a couple of days; I had lost a lot of blood and wasn’t stable but once I was, they flew me to Germany. I was there for a couple more days while they continued to monitor me and control the internal bleeding. Then, I was flown to the Walter Reed Army Medical Center in Washington, D.C. I was there for about three months and underwent multiple surgeries on my abdomen. There were also a lot of surgeries on my arm and wrist as they put them back together. I had to have therapy for the nerve damage due to the track of the bullet — there was a lot of work needed to reconfigure my internal organs,” he said.
“A year later, I still have several surgeries left to go on my left arm but we are at the microsurgery point. I’ve had bone transplants and there is still some tendon damage between my thumb and fingers but everything is going well. It’s just going to take time. I probably have another year of surgeries, recovery and therapy but it looks like it will get close to 95 percent recovered or better on the hand. Internally, the organs and digestive system — everything they had to take out and reconnect is fine. There are no issues there but they may have to do one more surgery to take care of some weak areas where they cut my abdomen open. Overall, I’m about 80-90 percent recovered,” he said.
Clifton anticipates another year of recovery but is getting back to normal. He is working out and running again; he’s even training to run the Columbus 10K on June 6.
As for his military career, Clifton plans to retire at the right time, having done more than enough to make his country proud. “By the time this is all said and done, I’ll be pushing the 18-year mark or so and will medically retire when I get to a certain point in my recovery. With a couple of combat tours and some other exercises, I think that’s a pretty good career,” he concluded. Clifton was touched by the outpouring of support from his wife’s hometown. His name appeared on many prayer lists while he was recovering.
His in-laws, Jim and Paul Langhals, appreciated it also.
“We were so grateful for the community supporting us,” Paula Langhals said. “It really meant a lot to Jim and I and Sarah, Sean and their family, also. Delphos is a great community.”